Senior Quality Engineer – Medical Devices (NPD Lead, CAPA)

ACE Partners; Austin (TX); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

401(k)

Unlimited PTO

Progression plan

Job summary

ACE Partners in Austin, TX, is seeking a Senior Quality Engineer to provide quality engineering leadership for new product development and product line support, ensuring compliance with federal, industry, and corporate standards.

The role requires a Bachelor’s degree in Engineering or Science and 4+ years in an FDA-regulated environment, with strong knowledge of cGMP, QSR, and ISO standards. ASQ CQE/CQA is a plus. This is an on-site, growth-oriented opportunity.

Qualifications

• Bachelor's degree in Engineering or science, or equivalent experience.
• 4+ years hands-on experience, ideally in an FDA-regulated industry (pharma, biomedical, medical device).
• Strong grip on cGMP, QSR, and ISO Standards; statistical methods and acceptance sampling.
• ASQ, CQE, or CQA certification a plus.

Responsibilities

• Lead Quality Engineering for new product development and transfer to manufacturing.
• Provide technical leadership resolving quality issues.
• Create, review, and approve protocols, process/product validations, and Design History File documents.
• Analyze non-conformances and drive CAPA.
• Perform internal and supplier quality system audits.
• Develop Validation Master Plans and Project Plans.
• Partner cross-functionally on design controls, risk management (FMEAs), and design verification/validation.
• Investigate and resolve CAPAs and customer complaints.

Education

Bachelor's degree in Engineering or Science

4+ years hands-on experience in FDA-regulated industry

CAPA / corrective action

cGMP / QSR / ISO Standards

Statistical methods and acceptance sampling

ASQ CQE/CQA certification a plus

Job description

ACE Partners in Austin, TX, is seeking a Senior Quality Engineer to provide quality engineering leadership for new product development and product line support, ensuring compliance with federal, industry, and corporate standards.

The role requires a Bachelor’s degree in Engineering or Science and 4+ years in an FDA-regulated environment, with strong knowledge of cGMP, QSR, and ISO standards. ASQ CQE/CQA is a plus. This is an on-site, growth-oriented opportunity.