Senior Manager, Quality – Combination Products, Compliance

* Monitor medical device standards for quality management system (QMS) updates to ensure adherence to global regulations
* Monitor device/combination product enforcement trends in the industry and develop recommendations and action plans for QMS improvement
* Participate in external industry committees and ensure compliance with applicable medical device and combination product regulations
* Participate in the development and rollout of device standards lists by product types and families
* Coordinate and lead the process mapping and change for the development, revision, and maintenance of applicable department SOP’s, job aids, and WI’s
* Engage with stakeholders across various functions when creating/revising QMS processes.
* Lead gap assessments against new regulations and relevant inspectional observations, and perform impact assessments as required
* Participate in evaluations of medical device reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions.
* Support medical device and combination product inspectional readiness activities and regulatory inspection responses
* Assist with internal and external audits and inspections, acting as an SME and providing follow-up support as required
* Support combination product complaints process and investigations and relay findings to the design and development team
* Evaluate information from a QA technical perspective to ensure appropriate analysis and risk prioritization
* Compile and analyze data, metrics, and trends associated with combination product processes.
* May manage Quality personnel (contract or FTE), including organizing and prioritizing daily tasks, conducting training, and writing performance reviews
* 8+ years of relevant experience with a Bachelor’s degree in a Science or Engineering field; or 6+ years of relevant experience with a Master’s degree in a Science or Engineering field
* Medical device manufacturing, testing or QA experience is essential.

Experience with combination devices (e.g., autoinjectors, co-packaged kits, pre-filled syringes) is preferred
* Demonstrated in-depth knowledge of Quality principles, concepts, industry practices, and standards
* Familiarity with end-to-end lifecycle QMS management
* Strong project management and process improvement skills
* Demonstrated keen understanding of U.S. and international quality systems regulations to adopt best-in-class systems and drive continuous improvement initiatives
* Knowledge of applicable standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366
* Preferred knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistics
* Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and/or FMEA is preferred.
* Certification by ASQ (such as CQA, CQE, or CQM) or other industry-recognized professional organizations is preferred.
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