Engineer III, Quality

MSD Careers • All, MD

16d

About The Position

The Quality Engineer III serves as a subject matter expert in planning and directing activities related to the development, application, and maintenance of quality standards for processes, materials, and products in accordance with the company’s Quality System. The role supports compliance with quality programs, plans, SOPs, policies, and active regulatory certifications, and mentors and/or supervises more junior QA team members. Responsibilities may be broad across the areas described or focused on areas requiring greater subject matter expertise, depending on departmental needs.

Requirements

• Bachelor’s degree in a technical, scientific, or engineering discipline.
• At least 7 years of experience in medical devices, in vitro diagnostics, pharmaceuticals, or a related industry, in positions of increasing responsibility.
• Intermediate-level knowledge of ISO 9001 quality system requirements.
• Strong quality fundamentals and analytical background.
• Logical problem-solving ability using TQM, team building, and quality systems tools and methods.
• Ability to organize and advance project tasks in an orderly and structured manner.
• Excellent oral and written communication and interpersonal skills.
• Ability to communicate issues, problems, and results that affect timelines, accuracy, and reliability of quality system data.
• Expert-level documentation and technical writing skills.
• Proficiency in MS Office Suite and capacity to learn additional software applications.
• Creativity and latitude, with the ability to multitask and work productively in demanding manufacturing and research environments with changing priorities.
• Ability to communicate and exchange information, use equipment necessary to perform the job, and move about the office.

Nice To Haves

• Master’s degree.
• Experience developing, implementing, and maintaining Quality System compliance.
• Experience planning and implementing quality plans and programs.
• Experience mentoring or training.
• Advanced technical training and experience using statistics, Lean, and Six Sigma methodologies, including Measurement System Analysis, SPC, DOEs, and Reliability.
• Relevant ASQ certification, such as CQE, CRE, or CQA.
• Working knowledge of FDA Quality System requirements (QSR) and the ISO 13485 standard.

Responsibilities

• Participate in New Product Development project teams and ensure compliance with QMS processes and procedures.
• Guide project teams on design control requirements and review design and development deliverables for conformity with internal and external requirements.
• Oversee maintenance of design history files and risk management files, and oversee supplier management activities for NPD projects.
• Represent Quality in validation activities covering equipment, processes, assays, spreadsheets, software, facilities, and utilities, and support projects under the Master Validation Plan.
• Develop validation strategies, guide revisions to validation procedures and protocols, analyze validation data, prepare documentation, and recommend changes or improvements.
• Oversee resources conducting validation activities for lower-complexity projects.
• Define, document, and continuously improve verification plans and protocols; conduct peer reviews and maintain traceability to requirements.
• Analyze data using hypothesis, normal distribution, and process capability analysis tests.
• Lead supplier quality investigations and support the Material Review Board by recommending or reviewing dispositions of non-conforming material.
• Lead internal and supplier audits as needed, ensuring they are performed, documented, and completed according to the annual audit procedure and schedule.
• Assist with external audits related to active regulatory certifications and customer audits.
• Direct the need for Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects.
• Ensure corrective and preventive actions are appropriately issued, investigated, documented, effective, and completed on time.
• Generate and analyze metrics to measure QMS effectiveness.
• Mentor and/or supervise more junior QA team members.

Benefits

• Medical, dental, vision, and prescription coverage.
• 401(k) plan with company matching.
• Flexible spending accounts.
• Company-paid short- and long-term disability insurance.
• Group life and accidental death and dismemberment insurance.
• Paid vacation, paid sick leave, paid holidays, and paid parental leave.
• Employee assistance program.
• Fitness club membership contribution.
• Pet insurance.
• Identity theft protection.
• Home and auto insurance discounts.
• Optional supplemental life insurance.
• Employees may qualify for discretionary or non-discretionary annual bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior