Senior Quality Engineer

TOP MUST-HAVES

1. Medical Device Experience — MUST HAVE

The manager is specifically looking for someone who has worked as a Quality Engineer / Engineer within medical device manufacturing.

Candidates from general manufacturing without medical device experience are less likely to qualify.

2. NCR + CAPA — VERY IMPORTANT

This was one of the clearest requirements from the manager.

Candidate must understand and ideally own:

• NCR – Non-Conforming Material/Nonconformance
• CAPA – Corrective and Preventive Action
• Quality investigations
• Product impact assessments
• Root cause analysis
• Disposition decisions

If the candidate doesn't know NCR and CAPA, manager indicated they are probably not qualified.

Manufacturing Process Experience

The engineer will support manufacturing processes involving:

• Laser welding
• Laser cutting
• Electropolishing
• Chemical processes
• Oxide removal
• Salt bath processes
• Acid processes
• Machining
• Other medical-device component manufacturing processes

Important: This is not an assembly-focused role.

They are manufacturing medical-device components and changing/controlling the properties of materials through manufacturing processes.

What Type of Engineer Does She Want?

The candidate should be someone who:

• Works independently
• Takes ownership
• Gets out on the manufacturing floor
• Works directly with production/engineering/quality teams
• Can investigate problems
• Can make technical decisions
• Can defend technical rationale
• Rolls up their sleeves rather than simply advising/coaching others

Manager's ideal candidate:

Senior-level engineer who can independently own quality problems and drive them to resolution.

What Manager Wants to See on the Resume

Don't just look for responsibilities.

Look for quantifiable accomplishments, such as:

• Led/closed multiple NCRs
• Led CAPAs
• Reduced nonconformances
• Improved manufacturing processes
• Developed/improved inspection or test methods
• Performed root-cause investigations
• Made product disposition decisions
• Developed technical rationale for product acceptance/salvage
• Supported process changes
• Improved yield/scrap/rework
• Worked cross-functionally with Manufacturing/R&D/Engineering/Operations
• Independently owned quality projects

Resume should demonstrate VALUE delivered, not just duties performed.

Validation Experience

IQ/OQ/PQ

Not the biggest differentiator.

Engineering generally performs the IQ/OQ/PQ work, while Quality reviews/approves it.

Candidate should understand the process and be capable of supporting/reviewing/signing off on validation documentation.

TMV – Test Method Validation

More important than IQ/OQ/PQ.

Candidate may need to execute TMV because TMV falls under Quality.

Look for:

• TMV protocols
• TMV execution
• Data analysis
• Validation reports
• Test method development/validation

Equipment / Tooling / Fixture Experience

This is not a primary requirement for the Quality Engineer.

Engineering teams are responsible for:

• Equipment design
• Tooling
• Fixtures
• Equipment improvements
• Equipment validation

Quality Engineering supports/signs off on engineering validation work and evaluates the impact on product/process quality.

So don't reject a strong Quality Engineer simply because they haven't designed fixtures or manufacturing equipment.

Education

Acceptable engineering/science backgrounds include:

Strong fits

• Mechanical Engineering
• Materials Science
• Chemical Engineering
• Chemistry
• Electrical Engineering
• Metallurgy
• Other relevant engineering/science disciplines

Weak fit

Biology was specifically mentioned as less suitable because this role requires strong process/manufacturing science and engineering knowledge.

Certifications

CQE

Preferred, NOT required.

Six Sigma

Helpful/preferred, but certification isn't necessarily mandatory.

Candidates with CQE/Six Sigma can potentially onboard faster, but certifications aren't deal-breakers.

Location / Schedule

Onsite

4 days onsite every week:

Monday – Thursday

10-hour shifts

Preferred:

12:00 PM – 9:00 PM

Alternative:

3:30 PM – 2:00 AM

Manager indicated the 12–9 PM shift may be easier to staff.

Relocation

Candidates can relocate at their own expense.

Company is not providing relocation/housing assistance.

Candidate must ultimately be in Utah.

Team Structure

This is NOT a team of eight people doing the same job together.

The candidate will be:

• An independent Quality Engineer
• Assigned to a particular manufacturing line/process
• Working alongside other Quality Engineers
• Able to receive/support knowledge from other QEs