Associate Director, Quality Assurance

Job Description

This Associate Director, Quality position provides medical device and combination product (MDCP) support to the site. Primary responsibilities to include providing overall site leadership to establish and then maintain site ISO 13485 certification. This position will also ensure new product launches for medical devices and combination products are following applicable regulatory requirements. The Associate Director will ensure that quality management systems are established and maintained in accordance with ISO 13485 standards. They will also be responsible for leading QMS gap assessments against regulations and company standards, hosting audits from Notified Bodies and FDA, and ensuring compliance with relevant regulations such as 21 CFR Part 4, QMSR, and EU MDR.

The MDCP Associate Director, Quality position is responsible for providing day to day tactical and strategic support to the site's MDCP program. Primary responsibilities include ensuring that high standards for MDCP compliance are maintained at the site and that key projects related to these products are supported allowing effective execution. Additional activities, responsibilities, and competencies include but are not limited to the following:

Compliance:

• Acts as site subject matter expert for MDCP related compliance. Ensure site operates within established MDCP policies, procedures, ISO standards, and applicable Health Authority regulations.
• Establish and maintain quality management systems compliant with ISO 13485 standards and relevant MDCP regulations.
• Conduct QMS gap assessments against applicable regulations and standards to ensure compliance.
• Stay updated with regulatory changes and industry best practices related to quality management systems and certifications.
• Prepare the company for MDCP related audits by Notified Bodies and FDA, including hosting audits and addressing audit findings.

Delivery:

• Provide Quality support to device assembly, packaging, and other site operations to rapidly resolve concerns and assure compliant and reliable customer supply.
• Provide Quality Assurance review and approval of MDCP related GMP documentation.
• Collaborate with cross-functional teams to implement corrective and preventive actions based on assessment findings.
• Resolve and escalate MDCP related concerns with the potential to impact product launches or supply.

Cost

• Ensure that activities are carried out in accordance with departmental budget.
• Recognize and implement opportunities for efficiency and financial savings.

People and Team:

• Provide guidance and training to employees on quality requirements and best practices related to MDCP standards and regulations.
• Support a positive culture of inclusion within the Quality team.
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.
• Build effective relationships with other functional areas as well as stakeholders across the company's network.

Strategic Support and Continuous Improvement:

• Support the company's ISO 13485 certification and lead the site efforts for medical device and combination products launch.
• Participate in continuous improvement initiatives to enhance the overall quality culture within the organization.
• Collaborate with internal and external stakeholders to establish and maintain effective quality processes and systems.
• Identify and implement opportunities for process optimization and efficiency in quality management.

Minimum Education Minimum Requirement and Experience:

• Bachelor's degree in Science or Engineering related field with eight (8) years of experience working in Quality for a medical device or combination products manufacturing organization.

Required Experience and Skills:

• Demonstrated experience maintaining quality management systems compliant with ISO 13485.
• Thorough understanding of ISO 13485, 21 CFR Part 4, QMSR, and EU MDR.
• Strong communication skills: ability to effectively communicate with cross-functional teams, auditors, and regulatory authorities.
• Attention to detail: meticulous in ensuring compliance with regulations and standards.
• Strong leadership and influencing skills: ability to drive change, influence stakeholders, and lead a team.
• Experience hosting audits by Notified Bodies and FDA.

Preferred Experience and Skills:

• Proven track record in leading QMS gap assessments against regulations and standards.
• Project management skills: ability to prioritize tasks, manage timelines, and meet deadlines.
• Problem-solving skills: ability to identify gaps, analyze complex issues, and develop effective solutions.
• Adaptability: able to work in a dynamic and fast-paced environment, adapting to changing priorities and requirements.
• Strong written and verbal communication skills including technical writing experience (investigations, change requests, standard operating procedures, protocols, etc.)
• Experience supporting regulatory inspections (FDA, EMA, etc.) and/or notified body audits.

NOTICEFORINTERNALAPPLICANTS

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.

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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".

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Job Posting End Date:

*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:08/27/2024

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:R309015