Current jobs related to Associate Director, Combination Product Quality Engineering and Quality Assurance - Lake Wales, Florida - Merck

  • Quality Assurance Manager

    3 weeks ago

    Lake Wales, Florida, United States MyKelly Full time

    MyKelly Quality Manager OpportunityMyKelly is seeking a dedicated Quality Manager to enhance our operations within a leading manufacturing environment. This position entails overseeing a quality assurance team, engaging with suppliers, and pinpointing areas for enhancement. If you possess a strong background in quality management and manufacturing processes,...

  • Quality Assurance Specialist

    3 weeks ago

    Lake Wales, Florida, United States iAnthus Capital Full time

    Job OverviewPosition SummaryThe Quality Assurance Specialist will collaborate with the Quality team to design, execute, oversee, and continuously enhance the quality and product initiatives at iAnthus Capital.Key Responsibilities:Conduct inspections of both in-process and finished goods to ensure compliance with quality assurance standards for extraction and...

  • Quality Assurance Specialist

    2 weeks ago

    Lake Wales, Florida, United States Chili's Grill & Bar Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Chili's Grill & Bar. As a Quality Assurance Specialist, you will play a critical role in ensuring that every guest receives perfectly prepared, high-quality food.Key ResponsibilitiesFood Preparation and Quality Control: Ensure that food is prepared to company...

  • Manufacturing Quality Lead

    3 weeks ago

    Lake Wales, Florida, United States MyKelly Full time

    MyKelly Quality Manager OpportunityMyKelly is seeking a dedicated Quality Manager to become a vital part of our esteemed organization. This position entails overseeing a quality assurance team, engaging with suppliers, and pinpointing areas for enhancement. If you possess a strong background in quality management and experience in the manufacturing sector,...

  • Manager of Quality Control

    3 weeks ago

    Lake Wales, Florida, United States MyKelly Full time

    MyKelly Quality Manager OpportunityMyKelly is seeking a Quality Manager to become part of a leading organization. This position entails overseeing a team dedicated to quality assurance, engaging with suppliers, and pinpointing areas for enhancement. If you possess a strong background in quality management and experience in the manufacturing sector, this role...

  • Quality Assurance Inspector

    3 weeks ago

    Lady Lake, Florida, United States Aerotek Full time

    Job OverviewPosition Summary:The Quality Assurance Inspector is tasked with ensuring that our cement products adhere to the highest quality benchmarks. This position involves supervising and executing quality assurance protocols, performing tests, and evaluating data to guarantee that our products are uniform and comply with regulatory and customer...

  • Quality Assurance Specialist

    3 weeks ago

    Lady Lake, Florida, United States Aerotek Full time

    Job DescriptionPosition: Quality Assurance SpecialistWe are looking for a diligent and detail-focused Quality Assurance Specialist to ensure that our products meet the highest standards. Your role will involve interpreting technical drawings, utilizing measuring tools, and conducting thorough inspections before and after production. Your sharp attention to...

  • Quality Assurance Specialist

    3 weeks ago

    Lady Lake, Florida, United States Aerotek Full time

    Job OverviewPosition Title: Quality Assurance SpecialistWe are in search of a precise and detail-focused Quality Assurance Specialist to enhance our operations. This role entails verifying that all products are manufactured accurately by interpreting technical drawings, utilizing measuring tools, and conducting thorough pre and post-production evaluations....

  • Quality Assurance Specialist

    3 weeks ago

    Lady Lake, Florida, United States Aerotek Full time

    Job OverviewPosition Title: Quality Assurance SpecialistWe are looking for three dedicated Quality Assurance Specialists to become part of our dynamic team. In this position, you will interpret technical drawings, utilize and interpret measurement tools, and apply your meticulous attention to detail to guarantee that all products are manufactured to...

  • Quality Assurance Specialist

    2 hours ago

    Lake Worth, Florida, United States Chili's Grill & Bar Full time

    Quality Assurance SpecialistAt Chili's Grill & Bar, we're committed to delivering exceptional dining experiences to our guests. As a Quality Assurance Specialist, you'll play a vital role in ensuring that every dish that leaves our kitchen meets our high standards of quality and taste.Key Responsibilities:Monitor food preparation to ensure consistency and...

  • Production Enhancement Specialist

    3 weeks ago

    Lake Wales, Florida, United States Rise Technical Full time

    Position: Manufacturing EngineerSalary: $85,000 - $100,000 + Excellent BenefitsLocation: Lake Wales, FloridaAre you a skilled Manufacturing Engineer seeking to join a dynamic and growing company that offers specialized training and numerous advancement opportunities?This is a fantastic chance to introduce innovative processes and methodologies while...

  • Quality Assurance Leadership Position

    1 week ago

    Lake Belvedere Estates, Florida, United States Infinity Systems Full time

    About Infinity SystemsInfinity Systems is a leading provider of innovative solutions in the food industry. Our commitment to excellence and customer satisfaction has earned us a reputation as a trusted partner in the market.Job SummaryWe are seeking an experienced Quality Assurance Manager to lead our quality assurance department. As a key member of our...

  • Food Quality Specialist

    6 days ago

    Lake Wales, Florida, United States Chili's Full time

    Role OverviewAt Chili's, we're committed to delivering exceptional dining experiences to our guests. As a Quality Assurance Specialist, you'll play a vital role in ensuring that every dish that leaves our kitchen meets our high standards of quality and taste.ResponsibilitiesMonitor food preparation to ensure consistency and qualityCollaborate with kitchen...

  • Healthcare Quality Assurance Specialist

    2 days ago

    Lake Mary, Florida, United States CornerStone Staffing Full time

    Remote Quality Assurance Specialist OpportunityWe are seeking a skilled Quality Assurance Specialist to support our team during our peak season. As a remote Quality Assurance Specialist, you will play a critical role in ensuring the accuracy and completeness of benefit verifications.Key Responsibilities:Review benefit verifications for accuracy and...

  • Healthcare Quality Assurance Specialist

    1 day ago

    Lake Mary, Florida, United States CornerStone Staffing Full time

    Remote Quality Assurance Specialist OpportunityWe are seeking a dedicated Quality Assurance Specialist to support our growing team during our peak season. As a Quality Assurance Specialist, you will play a critical role in ensuring the accuracy and completeness of benefit verifications.Key Responsibilities:Conduct thorough reviews of benefit verifications to...

  • Production Associate

    3 weeks ago

    Lake Wales, Florida, United States Gwynedd Manufacturing Full time

    Position OverviewGwynedd Manufacturing, a prominent player in the defense contracting sector, operates a cutting-edge production facility committed to delivering high-quality products for various governmental agencies. Our organization is dedicated to innovation and the continuous enhancement of our manufacturing processes.Key Responsibilities:Utilizing...

  • Software Quality Assurance Engineer

    2 weeks ago

    Lake Mary, Florida, United States Blue Ocean Ventures Full time

    Job OpportunityWe are seeking a highly skilled Automation Specialist to join our team at Blue Ocean Ventures. As a representative of our company, you will work closely with leading Global IT Management Consulting companies to fulfill their hiring needs in the United States.Key Responsibilities:Develop and implement automated testing frameworks using Core...

  • Senior Product Engineer

    4 days ago

    Lake Mary, Florida, United States Insight Global Full time

    Product Development and Engineering ExpertiseWe are seeking a highly skilled Senior Product Engineer to join our team at Insight Global. As a key member of our product development team, you will be responsible for designing, developing, and maintaining our products to meet the highest standards of quality and performance.Key Responsibilities:Product Design...

  • Marketing Associate

    6 days ago

    Lake Wales, Florida, United States Staffing Connection Inc. Full time

    Marketing Associate Job DescriptionAre you looking for a challenging role that combines sales, marketing, and customer service skills? Our client, a leading roofing and siding company, is seeking a Marketing Associate to join their team.Key Responsibilities:Generate leads and develop relationships to drive new business opportunities.Represent the company at...

  • Retail Sales Associate

    2 weeks ago

    Lake Wales, Florida, United States Batteries Plus Bulbs Full time

    About UsBatteries Plus Bulbs is a leading provider of battery and light bulb solutions, with a nationwide network of over 720 stores. We are committed to delivering exceptional customer service and providing a wide range of products to meet our customers' needs.Job SummaryWe are seeking a highly motivated and customer-focused Retail Sales Associate to join...

Associate Director, Combination Product Quality Engineering and Quality Assurance

4 months ago

Lake Wales, Florida, 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