Quality Engineer Senior

Regulatory Jobs; Trumbull (CT); On-site; USD 96,000 - 129,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Fertility benefits

Paid time off (vacation, personal, and

Holidays

Parental leave

Job summary

CooperSurgical in Connecticut seeks a Sr Quality Engineer to ensure the highest quality standards across manufacturing and product lifecycle. You will lead validation, IQ/OQ/PQ, CAPA, and change control while partnering with Manufacturing, R&D, Regulatory Affairs, and suppliers.

The role also involves mentoring junior engineers, supporting regulatory audits, and driving continuous improvement through Lean and Six Sigma, with strong data analysis and communication skills.

Qualifications

• In-depth knowledge of 21 CFR 820 and ISO 13485.
• Experience with cross-functional teams and regulatory environments.
• Hands-on experience with process validation, CAPA, nonconformance management, and change control.
• Strong time management and organizational skills; excellent English communication.

Responsibilities

• Lead quality engineering activities for manufacturing processes, including process validation and equipment qualification (IQ/OQ/PQ).
• Lead root cause investigations and CAPA using structured problem-solving methodologies.
• Lead nonconformance handling, deviations, disposition, and approval of nonconforming product.
• Support site leadership during audits and inspections; act as SME during FDA, notified body, and supplier inspections.
• Analyze quality metrics and drive continuous improvement using Lean, Six Sigma, or similar methodologies.
• Provide mentorship and guidance to junior quality engineers and quality inspectors.
• Collaborate cross-functionally with Manufacturing, R&D, Supply Chain, Regulatory Affairs, and others to ensure product quality and compliance.
• Lead reportable complaint investigations and coordinate with stakeholders (DQA, PMS, etc.).
• Support supplier quality activities, including supplier qualification and performance monitoring.
• Represent quality on cross-functional teams for NPI, design transfer, and manufacturing scale-up.
• Participate in other projects as required by quality management.
• Perform other duties as assigned.

Skills

Quality leadership

Root cause analysis

Problem solving

Communication skills

Time management

Cross-functional collaboration

Mentoring

Tools

Microsoft Excel

Microsoft Word

Outlook

PowerPoint

Job description

The Quality Engineer Sr will be responsible for ensuring the highest standards of quality throughout our organization and provide strategic thinking with a deep understanding of quality management systems, change control requirements & processes, and a proven track record of implementing and maintaining robust quality processes.

• Lead and support quality engineering activities for manufacturing processes, including process validation, equipment qualification (IQ/OQ/PQ), and change management.
• Lead root cause investigations and corrective and preventive action (CAPA) using structured problem-solving methodologies.
• Lead and support nonconformance handling, deviations, disposition, and approval of nonconforming product.
• Support site leadership during internal and external audits and inspections; act as a subject matter expert during FDA, notified body, and supplier inspections.
• Analyze quality metrics and trends; drive continuous improvement initiatives using Lean, Six Sigma, or similar methodologies.

• Provide mentorship and technical guidance to junior quality engineers and quality inspectors.

• Collaborate cross-functionally with Manufacturing, R&D, Supply Chain, Regulatory Affairs, and other groups to ensure product quality and compliance throughout the product lifecycle.
• Lead reportable complaint investigations and coordinate activities with other stakeholders (DQA, PMS, etc.).
• Where necessary, support supplier quality activities, including supplier qualification, performance monitoring, and issue resolution.
• Serve as quality representative on cross-functional teams for new product introduction (NPI), design transfer, and manufacturing scale-up.
• Participate in other projects as required by quality management.

• Perform other duties as assigned.

• In-depth knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other global standards.
• Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management, partnering across multidisciplinary teams (internal/external).
• Hands-on experience with process validation, CAPA, nonconformance management, and change control.
• Strong time management skills to drive multiple projects to completion on time.
• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
• Strong data analysis, negotiation, and problem-solving skills.
• Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
• Experience in participating in regulatory audits/inspections is required.
• Proficient in reading, writing, and communicating in the English language.

Our Benefits:

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.

Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

Pay transparency statement (CA, CO, CT, HI, IL, MD, MN, NJ, NY, VT, WA, or Remote):

For U.S. locations that require disclosure of compensation, the starting base payfor this role is between $96,000 - $128,588. The actual base payincludes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.