Overview
Senior Quality Specialist Jobs in Greater Minneapolis-St. Paul Area at Transcend
Title: Senior Quality Specialist
Company: Transcend
Location: Greater Minneapolis-St. Paul Area
Company Information
Transcend is a leader in the design and manufacture of innovative CPAP medical devices that improve the lives of patients worldwide. Our team is committed to delivering safe, effective, and high-quality products through a strong culture of quality, regulatory compliance, and continuous improvement.
We are seeking a Senior Quality Specialist to support and maintain our Quality Management System and ensure compliance with FDA and international regulatory requirements.
Overview of the Position
This role is responsible for supporting the Quality Management System (QMS) for Class II medical devices and working cross-functionally with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to ensure product quality and regulatory compliance.
This is a highly visible role with authority to prevent release of nonconforming products and ensure quality system compliance. The main focus of this role will be to own and maintain the site-wide complaint handling system.
This position is ideal for candidates who enjoy being hands-on in manufacturing quality, working in an eQMS, and driving quality system effectiveness.
Responsibilities
The primary responsibilities for this role include the following:
- Maintain and administer the electronic Quality Management System (eQMS) including Document Control, CAPAs, Nonconformances (NCMRs), Deviations, Equipment Management, Training, Complaint Handling
- Responsible for the Complaint Handling system which includes timely review and investigation of all customer complaints, medical device reporting (MDR), investigations with suppliers, review of servicing records, working with Engineering to investigate and update associated risk files and providing frequent updates to leadership on the status of the complaint handling system.
- Support compliance with FDA 21 CFR Part 820, ISO 13485, and MDSAP requirements
- Monitor quality system performance, identify trends, and drive improvements through data-driven decision making.
- Perform periodic reviews and update QMS documents to maintain effective, efficient, and compliant processes
- Support Engineering with new product development as the SME for Quality (includes approval of design and development files, supplier qualification, approval of test protocols and reports, etc.)
- Maintain Device Master Records (DMR) and Device History Records (DHR)
- Conduct employee training specific to the QMS
- Perform root cause analysis and support corrective actions for CAPAs and NCMRs
- Monitor QMS trends and support continuous improvement projects
- Support product release activities
- Provide quality support to Manufacturing and Engineering teams
- Participate in internal and external audits (FDA and MDSAP inspections)
- Maintain the supplier quality management system, including management of (SCARs)
Qualifications
Required Qualifications
- Bachelor’s degree in Biomedical Engineering, Life Sciences, or related field
- 6–10 years of direct Quality experience in medical device manufacturing and at least 3-5 years with Regulatory Affairs experience
- Experience working within FDA-regulated and ISO 13485 environments
- Experience with CAPA, nonconformance, document control, and training systems
- Experience working with electronic Quality Management Systems (eQMS)
- Strong analytical, documentation, and problem-solving skills
Preferred Qualifications
- Experience with CPAP, respiratory, or electro-mechanical medical devices
- Experience with Grand Avenue Software (strongly preferred)
- Experience supporting FDA inspections or MDSAP audits
- Lead Auditor certification or audit experience
- Experience with supplier quality or calibration systems
Physical / Work Environment
- Manufacturing environment with routine production floor presence
- Interaction with manufacturing, engineering, and regulatory personnel
- Participation in internal and external audits and inspections
Reports To
- Vice President of Quality and Regulatory
