Execute Quality engineering activities that support business and compliance needs, ensuring timely delivery of high‑quality outputs.
Apply technical, regulatory, and Quality systems knowledge to ensure compliance with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
Support harmonization and standardization of Quality processes, procedures, and tools across sites and functions to improve consistency and efficiency.
Partner with R&D, Regulatory Affairs, Manufacturing, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
Identify and support continuous improvement opportunities, including simplification, process excellence, and digital enablement within the Quality Management System (QMS).
Maintain a state of inspection readiness and participate in regulatory agency, notified body, and internal audit activities as a Quality representative.
Utilize Quality metrics and data analytics to identify risks, support root cause analysis, and implement sustainable corrective and preventive actions.
Mentor and provide technical guidance to peers and junior team members to strengthen organizational capability.
Communicate Quality‑related risks, progress, and recommendations to project teams and cross‑functional stakeholders.
Perform other work-related duties as assigned.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
Commitment to scientific integrity, compliance excellence, and continuous improvement.
Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline (preferred).
Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools (preferred).
Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise (preferred).
Experience supporting or leading Health Authority or Notified Body inspections (preferred).

Benefits

medical, dental, vision, life, and disability insurance
401(k) plan
employee assistance program
Employee Stock Purchase Plan
paid time off (including sick time)
paid Holidays

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality engineeringQuality Management System (QMS)data analyticsroot cause analysisprocess excellencecontinuous improvementregulatory complianceISO 13485FDA 21 CFR 820IVDR

Soft Skills

collaborationinfluencecommunicationanalytical skillsproblem-solvingmentoringorganizational capabilitycommitment to scientific integritycommitment to compliance excellenceadaptability

Certifications

Lean Six SigmaPMP