Exciting role for an ambitious and independent senior quality manager. Initial task to establish a scalable QMS within ISO 13485 for our greenfield combination product device production. Opportunity to grow into global role for medical device platform including several other medical devices segments. This role is handson and ideal for someone who thrives in earlystage environments and can balance regulatory rigor with startup speed.
Responsibilities
Quality System & Compliance
- Establish, implement, and maintain a scalable QMS aligned with ISO 13485 and combinationproduct expectations.
- Define core processes (design control, risk management, CAPA, change control, supplier quality, production QC).
- Prepare the company for certification audits and customer assessments.
Regulatory Affairs
- Lead regulatory strategy and execution for FDA and EMA submissions in collaboration with customers.
- Support customer programs requiring filings for combinationproduct devices.
- Provide guidance for commercialization in nonregulated or lightly regulated markets.
Product & Operations Support
- Oversee QA for design and development, ensuring robust design controls and risk management (ISO 14971).
- Oversee QC for incoming, inprocess, and final release for production.
- Support verification, validation, and humanfactors activities.
Team & Capability Building
- Build and mentor a small, crossfunctional QA/RA/QC team that supports both design and production.
- Develop quality competencies across the broader organization.
Customer & Partner Interface
- Act as the quality lead for customers, partners, and suppliers.
- Support technical documentation, quality agreements, and duediligence requests.
Qualifications
- Degree in Engineering, Life Sciences, Quality, or related discipline.
- 10+ years in Quality roles within medical devices or combination products.
- Direct experience with regulatory submissions (FDA/EMA).
Required Skills
- Proven experience with FDA and EMA submissions for medical devices and/or combination products.
- Strong understanding of ISO 13485, 21 CFR 820, and device development lifecycle.
- Familiarity with manufacturing quality control and supplier quality.
Preferred Skills
- Thrives in startup environments with shifting priorities.
- High integrity and commitment to patient safety and product reliability.
- Ability to build and develop a lean, highimpact Quality team.
- Strong communication skills, especially when interfacing with regulators, customers, and executives.
