Senior Quality Engineer

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

Senior Quality Engineer - Medical Device

Location: Austin, TX

I am working with a leading medical device manufacturer, specialising in innovative healthcare products. This role provides Quality Engineering leadership for new product development and product line support, ensuring compliance with federal, industry, and corporate standards.

Key responsibilities & Requirements

• 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 corrective/preventive action plans (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
• 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
• 401(k)
• Unlimited PTO
• Progression plan