New · posted Oct 15
Cook Medical · Medical Devices
Supplier Quality Engineer 2
- Bloomington, IN
- On-site
- Full-time
- Senior & Principal
Closes Oct 2, 2027 · 352 days left
The role
The Supplier Quality Engineer (SQE) is responsible for the qualification, approval, and ongoing monitoring of suppliers to ensure compliance with Cook Polymer Technology quality standards and regulatory requirements. Core responsibilities include the planning and execution of routine and for-cause supplier audits, maintenance of supplier quality agreements, MPIAs, NDAs, and associated supplier documentation, as well as the issuance, review, and follow-up of Supplier Corrective Action Requests (SCARs). The SQE provides quality engineering guidance and support to internal departments — including Operations, Engineering, and Quality Control — on all matters relating to supplier interfaces. This encompasses, but is not limited to, process and supplier validation, supplier change requests, non-conforming product issues, risk assessment, the Cook Polymer Technology Corrective and Preventive Action (CAPA) program, and associated Quality System documentation.
What you need
- B.S. in Engineering, Science, or a relevant technical discipline.
- Experience in Quality, Validation, or Statistics would be a distinct advantage.
- Proven knowledge and experience (ideally minimum 4 years) of working with ISO 13485, ISO 14971, the Medical Device Directive, EU Medical Device Regulation 2017/745 and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
- Qualified Lead Auditor in ISO 13485 and/or ISO 9001 is preferred and will be required in this role.
- Proven knowledge and experience of all aspects of Validation including Process Validation.
- Good working knowledge of statistics.
- Strong interpersonal skills with the ability to communicate effectively at all organizational levels.
- Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Skills named in this posting
What you'll do
- Perform supplier quality audits and supplier site visits; these are a key expectation of the role. Manage the supplier corrective action process and maintain and update the supplier audit schedule when required.
- Implement and develop mechanisms to monitor and identify supplier non-conformance trends based on risk.
- Track supplier quality performance measurements for suppliers (KPIs) and participate in supplier performance reviews. Completion and approval of supplier evaluations and monitoring when required.
- Manage and drive continuous improvement activities focusing on supplier quality; a strong inclination and proactive approach to identifying and implementing process improvements is a key expectation of this role.
- Review and support Supplier Change Notifications.
- Review and approval of raw materials, first part approval and supplier process validations.
- Maintain supplier quality documentation in conjunction with purchasing.
- Liaise with Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control for raw material issues.
- Provide input and support to the Cook Polymer Technology Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
- Support of the Internal Audit, Vendor Audit and Regulatory Audit Programmes.
- Completion of risk assessment of suppliers, non-conforming materials and CAPAs.
- Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
- Designee to the Senior Quality Engineer/Quality Engineering Team.
- Interaction with Cook Medical Holdings (parent company) on quality-related matters as required.
Where you'll work
Bloomington, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Bloomington, INJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in Indiana13 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Indiana (middle half) | $117,000 | $117,000 | $119,000 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Cook Medical's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk11
- GMP and compliance5
- Investigations and CAPA4
- Validation and qualification4
- Collaboration and leadership3
- Documentation and SOPs2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
Cook Medical on Regulatory Jobs
- 7
- Open roles
- 6
- Distinct roles
- 4
- Locations
By discipline
- Quality6 86%
- Regulatory1 14%
By level
- Senior & Principal4 57%
- Associate & Specialist3 43%
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Supplier Quality Engineer 2 at Cook Medical
Applications close October 2.