Description

You own quality engineering responsibilities within the medical device lifecycle.

This role is remote.

Responsibilities

• Manage medical device design and development risk using dFMEA and pFMEA.
• Author technical documentation including IQs, PQs, and TMVs.
• Oversee quality processes across upstream new product development and downstream manufacturing transfer.
• Ensure adherence to QSR 21 CFR 820, CMDR, EU MDD 93/42 EEC, JPAL, and ISO 13485:2016.
• Apply process validation and statistical methods to quality assurance activities.

Required Skills

• 5-7 years of work experience in Engineering and/or Quality (Bachelor's Degree required).
• Working knowledge of Quality System Regulation (QSR 21 CFR 820).
• Working knowledge of Canadian Medical Device Regulation (CMDR) and EU Medical Device Directive (EU MDD 93/42 EEC).
• Demonstrated working knowledge of process validation and statistical methods.
• Experience with risk management (dFMEA, pFMEA).
• Familiarity with JPAL and ISO 13485:2016.
• Experience with SAP QM.

Preferred Skills

• Green Belt Six Sigma/DRM Training/Certification.
• ASQ-CQE, CQA, CBA or equivalent certifications.
• SPC Software experience.

Key Skills

Education

Bachelor's degree