Freelance Quality Engineer Fda Jobs in Rochester, NY

The Senior Quality Engineer serves as a key Quality Assurance representative for contact lens manufacturing operations at the Rochester, NY facility. This role is accountable for ensuring compliance with applicable Quality Management System (QMS) requirements, including ISO 13485 and FDA 21 CFR Part 820, while driving continuous improvement in product and process quality.

The position provides technical leadership across the product lifecycle, including design transfer, process validation, manufacturing, and postmarket quality activities, ensuring alignment with Bausch + Lomb global standards and regulatory expectations.

The Senior Quality Engineer partners cross-functionally to implement risk based decision-making, support new product introductions, and lead quality improvement initiatives to enhance product performance, compliance, and operational efficiency.

Ensure compliance with QMS requirements, including:

• Nonconformance (NC) management and CAPA systems
• Change control and validation activities
• Document review and approval (DHRs, SOPs, specifications)
• Process validation (SAT/FAT/IQ/OQ/PQ/PV)
• Statistical sampling plans and data analysis
• Design transfer activities in accordance with design control requirements

Drive root‑cause investigations using structured methodologies:

• Ensure timely and effective containment, correction, and prevention

Perform data analysis and trending to:

• Identify emerging risks and quality signals
• Support decision‑making through statistical tools

Lead risk‑management activities aligned with ISO 14971, including:

• PFMEA development and maintenance
• Risk assessment, mitigation, and verification

Act as a quality lead for continuous improvement initiatives:

• Reduce scrap, defects, and cost of poor quality (COPQ)
• Improve manufacturing capability and process robustness

Ensure audit readiness and participate in:

• Internal audits
• External regulatory inspections (e.g., FDA, notified bodies)

Collaborate with cross‑functional teams (manufacturing, engineering, R&D, supply chain) to:

• Resolve quality issues
• Support product lifecycle activities
• Ensure alignment with design and regulatory requirements

Mentor junior engineers, quality technicians and provide technical guidance to operations personnel and peers.

The Senior Quality Engineer operates with a high level of independence and technical authority, influencing key quality decisions impacting product release and compliance. This role plays a critical part in:

• Supporting product commercialization and scale‑up
• Ensuring sustained manufacturing compliance
• Driving continuous improvement across operations

Minimal travel as required.

Education: Bachelor’s degree in science or related field required. Master’s degree preferred.

Minimum 10 years of relevant experience in Quality or Engineering in a medical device or regulated industry.

Strong working knowledge of:

• ISO 13485
• FDA 21 CFR Part 820

Experience with:

• CAPA and nonconformance systems
• Process validation and statistical analysis
• Lean Six Sigma methodologies (Green Belt or Black Belt preferred)

Demonstrated ability to:

• Lead and work with cross‑functional teams
• Influence decision‑making without direct authority
• Communicate effectively with internal stakeholders and external auditors

Experience with MES, statistical software, or data visualization tools (Minitab, Power BI, AI).

The estimated salary range for this position is between $95,200 and $128,800. The actual base salary offered may depend on a variety of factors. U.S. based employees may be eligible for short‑term and/or long‑term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays, and paid vacation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.