Quality Engineer

Position Title: Quality Engineer

Work Location: Draper, UT 84020

Assignment Duration: 9 Months

Work Arrangement: Onsite

Position Summary:

• This is a hands-on validation role inside a regulated medical device manufacturing site.
• The person hired into this seat spends the majority of the week on the production line executing Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Test Method Validation (TMV) activities, and spends the balance of the week producing the documentation record that supports those activities.

Background & Context:

• Equipment and process validation is the priority of this role. Investigations, nonconformance support, and general manufacturing quality support are secondary and follow the validation calendar.
• We are not hiring someone who can explain validation.
• We are hiring someone who has personally executed it, on equipment, in a live manufacturing environment.

Key Responsibilities:

• Execute IQ, OQ, PQ, and TMV protocols hands-on, including equipment setup verification, feasibility builds, sample generation, and data capture
• Own execution accuracy so validation runs do not have to be repeated and the schedule is not lost
• Work side by side with frontline manufacturing operators throughout OQ and PQ activities
• Build and compile validation documentation: protocol packets, executed records, summary reports, and supporting attachments
• Investigate deviations that surface during validation execution, establish root cause, and carry corrective actions to closure
• Raise and work observations that fall short of a formal deviation but still warrant investigation
• Support root cause investigations on NCRs once PQ builds and commercial work orders begin
• Provide manufacturing quality support after validation activities close out
• Keep all validation activity aligned to FDA 21 CFR Part 820, ISO 13485, GMP, and internal QMS requirements.

What a typical week looks like:

• Roughly 50 to 60 percent of the time is spent on the line: feasibility builds, equipment setup verification, IQ execution, OQ and PQ runs, sample generation, and direct work alongside frontline operators.
• The remaining 40 to 50 percent is documentation work, building the validation record set required for commercial launch.
• The mix shifts with project phase.
• The first stretch after start date is IQ execution and OQ preparation, which means heavy line time early.

Scope Boundaries:

• Protocol authorship is a shared function on this team.
• This role contributes to protocol development, but every protocol is reviewed and approved by a cross functional group, so independent authorship that clears QA on the first pass is not a screening bar for this position.
• CAPA ownership is not expected.
• NCR ownership is possible depending on the situation, but is not typical and is not a requirement.

Qualification & Experience:

• Demonstrated hands-on execution of IQ, OQ, PQ, and TMV in a medical device manufacturing environment. Execution, not oversight. Candidates must be able to name specific protocols they personally ran and the equipment they ran them on.
• Proven ability to learn unfamiliar production equipment and qualify it. Candidates should be able to walk through how they came up to speed on a piece of equipment and what validation work they executed on it.
• Working knowledge of FDA 21 CFR Part 820 and ISO 13485. Any regulated medical device manufacturing background is acceptable. Cardiovascular, Class III, and delivery system experience is welcome but is not required, and specific equipment types are not required.
• Deviation investigation and root cause experience using structured methods such as 5 Why, Fishbone, or Fault Tree Analysis
• Working knowledge of validation lifecycle documentation, change control, and risk management processes
• Technical writing strong enough to produce clean, audit ready validation records
• Comfort spending most of the day on a production floor with operators, engineers, and quality staff
• Ability to take a defined task on a piece of equipment and complete it without daily direction, while still operating inside a collaborative team
• Bachelor's degree in engineering required
• 2 to 4 years of relevant experience

Helpful, not required:

• SPC, Minitab, DOE, Gage R&R, process capability analysis, PFMEA participation, and technical drawing interpretation. These strengthen a profile. None of them substitute for execution history.

Team and Collaboration:

• Sits within the Quality organization at the Draper manufacturing site.
• Partners daily with a Quality Engineer on the same team and works closely with three Manufacturing Engineer counterparts on site.
• Regular collaboration by Teams and email with the NPD group at the Irvine location, roughly three to four Manufacturing Engineers and three to four Quality Engineers.
• Several standing meetings per week, plus constant day to day contact with manufacturing operators.

Working Conditions & Physical Demands (If Applicable):

• Comfort spending most of the day on a production floor with operators, engineers, and quality staff.

Additional Information (If Applicable):

• If a candidate is strong in validation or strong in investigations but not both, validation wins.

Applicant Notices & Disclaimers

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws