Senior Quality Engineer: Process Validation & Compliance

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

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.