Associate Director, Quality Assurance

Merck; North Wales (Montgomery County); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

Paid holidays and vacation

Job summary

Merck is seeking an Associate Director of Quality Engineering & Quality Assurance to provide independent compliance support for medical devices and device components of combination products. The role collaborates with cross-functional teams, reviews regulatory documentation, and guides design control, CAPA, and risk management to ensure regulatory and company standards.

You will contribute to policy development, stay current with global regulations, and support end-to-end quality oversight

Qualifications

• Bachelor’s degree in Science or Engineering with related experience or higher degrees with fewer years of experience.
• Experience with medical device regulations and quality systems.

Responsibilities

• Act as DQ&R Quality function representative on cross-functional teams.
• Review and approve design control and device risk management docs for regulatory filings.
• Develop/update policies and procedures for DQ&R Quality.
• Provide guidance to Manufacturing and R&D device functions for end-to-end design control.
• Lead design reviews, CAPA reviews, and ad-hoc technical reviews of combo products.

Skills

Clinical Quality Assurance

Combination Products

CSV

Design Thinking

Detail-Oriented

GMP Compliance

GCP

GMP

Interpersonal Relationships

Project Management

Lean Six Sigma

Manufacturing Audits

Quality Assurance (QA)

Quality Control Management

Quality Improvement Programs

Medical Device Regulations

Education

Bachelor’s degree in Science or Engineering or associated fields

Master’s degree in Science or Engineering or associated fields

Ph.D. in Science or Engineering or associated fields

Tools

None specified

Job description

Job Description

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, <10% of the time

Required Skills

Clinical Quality Assurance, Clinical Quality Assurance, Combination Products, Computer System Validation (CSV), Design Thinking, Detail-Oriented, External Partners, GMP Compliance, Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Interpersonal Relationships, Leading Project Teams, Lean Six Sigma (LSS), Manufacturing Audits, Manufacturing Compliance, Material Specifications, Medical Device Management, Medical Device Regulations, Medical Devices, Product Development, Project Management, Quality Assurance (QA), Quality Control Management, Quality Improvement Programs, Quality Standards {+ 2 more}

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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 offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance