Quality Specialist - Post-Market Surveillance (Complaints)

Overview:
We are seeking an experienced Quality Specialist to support post-market surveillance activities with a focus on complaint handling tied to service and repair operations. This individual will play a key role in evaluating, investigating, and processing product complaints while collaborating closely with service and repair teams to drive timely and compliant resolution.

Day-to-Day Responsibilities:
- Review, assess, and document product complaints in alignment with post-market surveillance requirements
- Perform complaint investigations, including evaluation of service and repair data to determine reportability and classification
- Partner cross-functionally with service and repair teams to gather relevant technical information and support root cause analysis
- Support and execute CAPA activities related to complaint trends and investigation outcomes
- Maintain accurate and compliant documentation in quality systems
- Contribute to continuous improvement initiatives within Quality Operations related to complaint handling and post-market processes

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, 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 View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:


Required Skills & Experience
- 7-10 years of experience in Quality within a regulated industry (medical device preferred)
- Strong background in complaint handling and post-market surveillance
- Prior experience supporting or working alongside service and repair functions
- Hands-on experience with CAPA and investigation processes
- Solid understanding of Quality Operations and regulatory requirements (e.g., FDA, ISO)
- Ability to determine complaint validity, classification, and escalation pathways
- Strong documentation and cross-functional communication skills


Nice to Have Skills & Experience
- Experience with complaint trending and data analysis
- Familiarity with electronic quality management systems (eQMS)
- Experience supporting field actions or post-market remediation efforts


Benefit packages for this role will start on the 1st 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.