The Quality Engineer II plays a critical role in ensuring that the Quality Management System (QMS) for assigned business units complies with applicable FDA regulations (21 CFR Part 820), ISO 13485, and current Good Manufacturing Practices (cGMP). This role supports continuous improvement initiatives and ensures that quality processes are robust, validated, and aligned with regulatory expectations for medical device manufacturing. This position reports to the Healthcare Global Quality Manager and collaborates closely with the E&I Quality Network to drive compliance and operational excellence.
Key Responsibilities
- Lead and support root cause investigations for internal non-conformances and FDA-reportable events (e.g., MDRs, CAPAs), using structured problem-solving tools such as 5 Whys, Ishikawa diagrams, FMEA, and hypothesis testing.
- Ensure compliance with 21 CFR Part 820, including Design Controls, Document Control, CAPA, Production and Process Controls, and Complaint Handling.
- Develop and maintain risk management documentation in accordance with ISO 14971 and support design and process FMEAs.
- Conduct statistical analysis (e.g., ANOVA, regression, control charts) to assess process capability and product performance; recommend actions based on data-driven insights.
- Lead validation activities (IQ/OQ/PQ) for equipment, processes, and software systems used in regulated environments.
- Manage nonconforming product investigations, including disposition and documentation per QMS procedures.
- Support internal and external audits, including FDA inspections and Notified Body audits; ensure timely closure of audit findings.
- Collaborate with cross-functional teams to implement design and process changes through formal change control systems.
- Drive supplier quality management activities including qualification, audits, and performance monitoring.
- Author and revise controlled documents including SOPs, work instructions, test methods, and quality plans.
- Lead or support customer complaint investigations, ensuring timely and thorough responses aligned with regulatory expectations.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
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- Bachelors degree in Engineering, Life Sciences, or related technical discipline.
- Minimum 5 years of experience in a quality engineering role within a FDA-regulated medical device or pharmaceutical environment.
- Strong working knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971, and cGMP.
- Experience with statistical tools and hypothesis testing for root cause analysis and process improvement.
- Proficient in quality systems software (e.g., LIMS, SAP, TrackWise, MasterControl) and data analysis tools (Excel, Minitab, JMP).
- Demonstrated success in leading CAPA investigations, validation projects, and audit readiness activities.
- Six Sigma Green Belt or higher certification preferred.
- Excellent communication skills with the ability to translate complex technical and regulatory information into clear, actionable insights.
- Experience with risk-based decision making, design control, and regulatory submissions is a plus.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.