Sr Engineer, Quality Operations (CDxGMP)

Pay Range: $90000.00 - $110000.00 / year

Salary offers are based on a wide range of factors including relevant skills training experience education and where applicable certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

Benefits Information:

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy happy lives. Our pay and benefit plans have been designed to promote employee health in all respects physical financial and developmental. Depending on whether it is a part-time or full-time position some of the benefits offered may include:

Day 1 Medical supplemental health dental & vision for FT employees who work 30 hours

Best-in-class well-being programs

Annual no-cost health assessment program Blueprint for Wellness

healthyMINDS mental health program

Vacation and Health/Flex Time

6 Holidays plus 1 MyDay off

FinFit financial coaching and services

401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service

Employee stock purchase plan

Life and disability insurance plus buy-up option

Flexible Spending Accounts

Annual incentive plans

Matching gifts program

Education assistance through MyQuest for Education

Career advancement opportunities

and so much more!

The Senior Quality Operations Engineer Quality Operations is an experienced quality engineering professional responsible for independent ownership of complex production and process control activities supporting IVD design transfer commercial manufacturing and sustained process performance.

This role applies deep technical judgment to investigations process validation change control supplier quality issues and operational quality decisions and is expected to coach others while serving as a strong cross-functional partner.

• Independently lead complex quality engineering activities across receiving inspection acceptance activities manufacturing support and process control execution.
• Lead technical investigations for nonconformances deviations process failures material issues and recurring quality trends; identify robust root causes and drive timely resolution.
• Develop review and approve validation protocols and reports for equipment qualification process validation revalidation and validation changes ensuring scientifically sound rationale and compliant execution.
• Lead quality review of production and process changes ensuring change impact is appropriately assessed for product quality regulatory compliance validation state and risk controls.
• Provide quality engineering leadership during design transfer and manufacturing readiness activities including control plan review inspection strategy process risk evaluation and readiness assessments.
• Partner with supplier quality Manufacturing and operations teams on supplier-related nonconformances SCARs incoming quality trends and qualification-related issues.
• Drive CAPAs and quality improvement actions for systemic manufacturing and process control issues; challenge weak problem statements unsupported root causes and ineffective actions.
• Review and approve engineering and quality documentation within delegated authority including protocols reports nonconformance records CAPAs change records and related technical assessments.
• Support audits regulatory inspections and back-room documentation for manufacturing quality topics; help ensure evidence is technically complete and inspection ready.
• Mentor junior engineers and technicians on GMP expectations GDP investigations risk-based decision-making and validation discipline.
• Generate and interpret quality metrics for process capability nonconformances CAPA performance supplier quality and operational trends and escalate adverse signals appropriately.

Required WorkExperience:

• 5 years of progressive experience in quality engineering manufacturing quality or quality operations in a regulated medical device or IVD environment.
• Strong working knowledge of FDA QMSR ISO 13485 GMPs process validation and production/process control requirements.
• Demonstrated experience supporting design transfer equipment qualification process validation supplier quality investigations CAPA and change control.
• Ability to make technically sound risk-based quality decisions with limited supervision.
• Strong facilitation influencing technical writing and structured problem-solving skills.
• Working knowledge of eQMS and quality analytics tools.

Preferred Work Experience:

• Experience in IVD product development design change governance or sustaining product design and development product lifecycle support.
• Experience in complex IVD manufacturing environments involving reagent consumable software-enabled or instrument-based products.
• Working knowledge of ISO 14971 statistical techniques process capability methods and electronic quality systems.

Physical and Mental Requirements:

• Strong attention to detail for thorough documentation to ensure consistency in documentation.
• Excellent problem-solving skills to identify and address quality issues effectively.
• Ability to manage multiple projects to meet deadlines while maintaining accuracy.

Knowledge:

• Strong working knowledge of FDA QMSR ISO 13485 ISO 14971 and practical application of risk-based quality system management.

Skills:

• In-depth knowledge of QMS standards and regulatory requirements relevant to manufacturing
• Ability to balances speed compliance and product quality without compromising patient safety product performance or regulatory expectations.
• Excellent cross-functional collaboration skills

• Strong communication skills for effective interaction with internal teams suppliers and regulatory bodies

Education:

• Bachelors degree in Engineering Life Sciences Biomedical Sciences or other relevant technical disciplines. (Required)