What are the responsibilities and job description for the Quality Engineer II - Medical Device position at Planet Pharma?
Quality Engineer II
Location: Draper, UT (On-Site)
Duration: 6 Month Contract (May extend or convert to permanent)
Target Pay Rate: $43/hour W2
The Opportunity
We are seeking a detail-oriented Quality Engineer II to support a major facility transition. We have recently completed construction on a state-of-the-art manufacturing building and are preparing to move our production lines for metal implantable heart valves.
This role is critical in ensuring all equipment and processes remain compliant and high-performing during the transition. You will work closely with the Project Engineering Lead to manage requalification and validation activities as we move into our new home.
What You’ll Do
- Phase 1 (First 2~ Months): Primarily desk-based. You will focus on prep work, planning activities, and writing validation protocols.
- Phase 2 (Months 3 ): On-floor execution. You will support the physical move of lines, execute protocols, and conduct validation/requalification activities.
- Documentation: Create, execute, and review IQ/OQ/PQ protocols and reports associated with requalification and validation.
- Compliance: Support process confirmation, calibration, and equipment testing (including inspections and test methods) to ensure medical device standards are met.
- Collaboration: Work within cross-functional teams to ensure a seamless transition between buildings.
Required Qualifications
- Education: Completed Bachelor’s degree in Engineering is required.
- Experience: 2–4 years of experience as a Quality Engineer within the medical device industry.
- Validation Expertise: Proven ability to create and execute protocols and reports related to qualification and validation activities (manufacturing lines, inspections, test methods, etc.).
- Communication: Strong verbal and written communication skills for technical reporting and team collaboration.
- Soft Skills: Must be a team player with high creativity, analytical problem-solving abilities, and a strong orientation toward detail and accuracy.
Preferred Skills
- Experience with automated equipment validation.
- Background in metal implantable manufacturing or heart valve production.
Salary : $43