See more Collapse

Associate Director, Combination Product Quality Engineering and Quality Assurance

1 month ago

Indianapolis, Indiana, United States Merck Full time

Job Description

Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to:

Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality Assurance Operations team, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of employees. Activities will include developing, documenting, and maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk

Management (ISO and other worldwide regulations and our Compa requirements.

This position provides Device quality engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products.

Primary activities include, but are not limited to:

  • Actively represent MDCP Quality function on commercial and product/core development teams supporting quality issues related to medical devices or the device constituent of a combination product.
  • Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing surveillance.
  • Evaluate deficiencies and assess impact on compliance status.
  • Contribute to developing/revising policy and procedures for MDCP Quality and/or supported areas.
  • Remain informed of industry trends as described in worldwide regulations and industry standards.
  • Provide guidance to our Manufacturing Division and our Research & Development Division device functions and other personnel to ensure end-to-end Design Control principles are implemented effectively.
  • Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combination products.
  • Participate in all stages of combo product development including but not limited to oversight of purchasing controls and supplier quality.
  • Work with external partners to develop products.
  • Review and approve verification/validation test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
  • Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
  • Facilitate translation of customer needs into critical to quality and design input/output requirements, including but not limited to chemical, physical, or performance specifications.
  • Lead and manage development of Global Design file (GDF) (Design History File-DHF) deliverables for medical devices

Skills:

  • Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO
  • Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
  • Risk Management experience (ISO , ICH Q9).
  • Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices.
  • Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
  • A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
  • Ability to work in a matrix organization and effective written and oral communicator.

Preferred experience and skills:

  • Remediation experience is desired.
  • Knowledge of current GMPs for combination products.
  • Certified Lean Six Sigma Green Belt or Black Belt or ASQ (American Society for Quality) certifications are preferred.
  • Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (QDP); and project management principles is desirable.
  • Lean Six Sigma Principles and tools such as: DOEs, Root cause analysis and/or Problem-solving methods are desired.
  • Experience in the use of root cause analysis and applied statistical techniques.

Qualifications:

  • A bachelor's degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR a master's degree (Science or Engineering or associated fields) and 5 years related experience or a Ph.D. (Science or Engineering or associated fields) and 3 years of related experience

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE $)

Current Contingent Workers apply HERE $)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here ) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights )

EEOC GINA Supplement​

Pay Transparency Nondiscrimination )

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts )

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/15/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 06/15/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R296142


We have other current jobs related to this field that you can find below

  • Quality Assurance Batch Release Associate

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance Complaints Representative

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Principal - Quality Assurance

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Consultant-Quality Assurance

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance Specialist

    2 weeks ago

    Indianapolis, Indiana, United States Actalent Full time

    JOB DESCRIPTION Actalent is Hiring a Quality Assurance Specialist (Indianapolis, IN) Description: The Quality Assurance Specialist will be responsible for oversight of the quality systems, production, quality laboratory, quality technicians. ect. This Specialist will work along side the quality manager to provide supervision, oversight, and...

  • Quality Assurance Specialist

    2 weeks ago

    Indianapolis, Indiana, United States Ingredion Incorporated (NA-US) Full time

    JOB TITLE: Quality Assurance Specialist LOCATION: Indianapolis, Indiana, USA REPORTS TO: Quality Assurance Manager The Quality Assurance Specialist will support the treating and drying unit by ensuring that unit activities related to food safety and quality follow the company, plant, regulatory and customer requirements. Core...

  • Quality Assurance Specialist

    2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director

    2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director – Data Products Engineering Lead

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director- Engineering

    3 weeks ago

    Indianapolis, Indiana, United States Lilly Full time

    Job DescriptionAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back...

  • Quality Assurance Specialist

    1 month ago

    Indianapolis, Indiana, United States Bristol Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Inspector/Quality Assurance- Production

    1 month ago

    Indianapolis, Indiana, United States teamworkonline Full time

    LEGENDS Founded in 2008, Legends is a premium experiences company with six divisions operating worldwide – Global Planning, Global Sales, Global Partnerships, Hospitality, Global Merchandise, and Global Technology Solutions – offering clients and partners a 360-degree data and analytics fueled service solution platform to elevate their brand and execute...

  • Food Safety Quality Assurance

    1 month ago

    Indianapolis, Indiana, United States Hungryroot Full time

    Who We Are Hungryroot is the all-in-one recipe and grocery service. We're here to help people feel their best and make grocery shopping, cooking, and enjoying healthy food easier than ever. So, we're creating the first-of-its-kind food experience that puts people (and the planet) first, built for busy lives and individual needs. This position is based...

  • Quality Engineer

    3 days ago

    Indianapolis, Indiana, United States ATS Automation Full time

    This individual supports Comecer Project Managers in the management of the orders from a quality point of view throughout the project including design reviews, FAT, SAT, IQ, OQ and some aspects of PQ as they relate to VPHP cycle development. This position will include activities for Radiopharma, Pharma and Cell & Gene Therapy (ATMP) projects in North...

  • Principal Associate-Quality

    2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director

    1 month ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Quality Assurance Manager

    2 weeks ago

    Indianapolis, Indiana, United States AppleTree Staffing Full time

    Job DescriptionJob DescriptionAppleTree Staffing is actively seeking a dedicated Quality Assurance Manager to join our client's team on the southwest side of Indianapolis.Why Choose Us:Industry Leader: Our client is an industry leader in the aerospace sector with a remarkable 70-year history.Job Stability: Be part of a team that values long-term commitment...

  • Authorized Quality Representative

    1 week ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Associate Director

    2 weeks ago

    Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...