Associate Director, Quality Assurance

Merck; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

Merck is seeking an Associate Director of Quality Engineering & Quality Assurance to lead independent compliance support for medical devices and device components of combination products. The role interfaces with cross-functional teams, reviews regulatory filings, and oversees design control, risk management, and supplier quality to ensure adherence to 21 CFR 820, ISO 13485, and related standards.

The position emphasizes leadership in quality oversight, document review, and collaboration across

Qualifications

• 7+ years of experience in quality engineering/assurance for medical devices or combination products.
• Strong knowledge of 21 CFR 820, 21 CFR Part 4, EU MDR, ISO 13485.
• Experience with Design Controls, CAPA, and purchasing controls related to 21 CFR 820.
• Solid risk management experience (ISO 14971/24971, ICH Q9).
• Excellent communication and cross-functional collaboration skills.
• Ability to work independently in a matrix organization with strong technical writing ability.

Responsibilities

• Represent DQ&R Quality in cross-functional teams for device quality issues.
• Review and approve design controls and device risk management documentation for regulatory filings.
• Develop and revise DQ&R policies and procedures.
• Stay informed on worldwide regulations and industry standards.
• Guide Manufacturing and R&D device functions to ensure end-to-end Design Control implementation.
• Participate in design reviews, CAPA reviews, and supplier quality oversight.
• Work with external partners on product development and verification/validation protocols.
• Contribute to material specifications, drawings, inspection and manufacturing procedures.

Skills

7 years experience

Regulatory knowledge

Design Controls

CAPA

Purchasing Controls

Risk Management

Communication skills

Independent work

Technical writing

Matrix organization

Written and verbal communication

Education

Bachelor's degree in Science or Engineering

Master's degree in Science or Engineering

PhD in Science or Engineering

Tools

CSV (Computer System Validation)

Job description

Job Description

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

Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), 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 14971) and other worldwide regulations and company 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

• Actively represent DQ&R 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 DQ&R 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 and 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 Design and Development File deliverables for medical devices

Skills

• 7 years of relevant work experience.
• Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485).
• Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
• Risk Management experience (ISO 14971/24971, 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

US based - NJ/PA or other US location

Travel - Yes,

Required Skills

Clinical Quality Assurance, Clinical Quality Assurance, Combination Products, Computer System Validation (CSV), Design Th