Remote Associate Director, Quality Engineering & Compliance

Merck; Dover (DE); Remote; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision plan

401(k)

Paid holidays

Vacation days

Sick leave

Job summary

Merck in Rahway, NJ is seeking an Associate Director Quality Engineering & Quality Assurance to lead independent compliance support for medical devices and device components of combination products. You will work with cross-functional teams to develop and maintain evidence, review regulatory filings, and ensure adherence to 21 CFR 820s, ISO 14971, and related standards.

You will guide Design Control, CAPA, and purchasing controls, mentor teams, and contribute to policy development while staying

Qualifications

• Bachelor’s degree in Science or Engineering with 7+ years related experience.
• Master’s degree in Science or Engineering with 5+ years related experience.
• Ph.D. in Science or Engineering with 3+ years related experience.

Responsibilities

• Represent DQ&R Quality on commercial and product/core development teams.
• Review and approve Design Control and Device Risk Management documentation for regulatory filings.
• Contribute to developing/revising policy and procedures for DQ&R Quality and supported areas.
• Remain informed of industry regulations and standards.
• Provide guidance to Manufacturing and R&D device functions to ensure end-to-end Design Control.
• Participate in design reviews, CAPA reviews, and ad-hoc technical reviews of combo products.
• Participate in all stages of combo product development including oversight of purchasing controls and supplier quality.
• Work with external partners to develop products.
• Review and approve verification/validation test protocols and reports to meet regulatory requirements.
• Provide input to design/manufacturing documentation to ensure producibility and testability.
• Translate customer needs into critical-to-quality inputs/outputs and specifications.
• Lead and manage Development File deliverables for medical devices.

Skills

Regulatory compliance

Quality engineering

Quality assurance

Design controls

CAPA

Risk management

GMP/QMS

Written communication

Project management

Cross-functional collaboration

Education

Bachelor’s degree in Science or Engineering

Master’s degree in Science or Engineering

Ph.D. in Science or Engineering

Job description

Merck in Rahway, NJ is seeking an Associate Director Quality Engineering & Quality Assurance to lead independent compliance support for medical devices and device components of combination products. You will work with cross-functional teams to develop and maintain evidence, review regulatory filings, and ensure adherence to 21 CFR 820s, ISO 14971, and related standards.

You will guide Design Control, CAPA, and purchasing controls, mentor teams, and contribute to policy development while staying