Senior Quality Engineer

Position: Senior Quality Engineer Req#: 19578-1: 4 Openings

Location: Draper UT(100% Onsite)
Duration: 12Months Contract with the possibility of extension/conversion

Job Description:

Take personal ownership of assigned individual CAPAs and all related processing from issue assessment and containment through root cause action plan execution implementation verification and effectiveness check closure in compliance with ISO 13485:2016 (Clauses 8.5.2/8.5.3) and 21 CFR 820.100.

Education and Experience:

• Bachelors degree in engineering required.
• 5 years experience required.

Job Responsibilities:

• Support overall CAPA process acceleration: drive assigned records to committed due dates reduce cycle time and aging escalate blockers early and hold cross-functional task owners accountable.
• Lead structured root cause investigations using 5 Whys Fishbone/Ishikawa Fault Tree Analysis and 8D/DMAIC documenting conclusions with clear defensible technical rationale.
• Author high-quality investigation reports and CAPA documentation that withstand FDA Notified Body and internal audit scrutiny strong technical writing is a core requirement of this role.
• Ensure documentation compliance across all assigned records: complete accurate traceable and contemporaneous entries in the eQMS with full data integrity and GDP adherence.
• Support Quality System updates and modifications including revisions to SOPs work instructions forms DHRs and inspection methods resulting from CAPA actions.
• Partner with Manufacturing Operations R&D and Supplier Quality on the floor to implement corrections and corrective/preventive actions and confirm actions do not adversely affect finished product or patient safety.
• Define and execute effectiveness check methodology applying statistical techniques and trend analysis of NC complaint and audit data to confirm sustained resolution; present record-level status at the CAPA Review Board.
• Preferred: eQMS experience (TrackWise Agile Veeva or equivalent) Class II/III implantable or combination device experience CQE/CQA.

Why TalentBurst
At TalentBurst we deliver more than talent we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.