Senior QMS Auditor & Compliance Leader

A-dec, Inc. (USA); Newberg (OR); On-site; USD 80,000 - 100,000; Full time

Job summary

A-dec, Inc. in Newberg, Oregon, is seeking a Senior Quality Assurance Specialist responsible for maintaining compliance with Quality Management System (QMS) standards in the medical device sector. The successful candidate will manage internal audits, liaise with third-party inspectors, and ensure efficient business processes.

Applicants should have a Bachelor's degree and at least four years of relevant experience, demonstrating strong project management skills and a profound understanding of international medical device regulations.

Qualifications

• At least 4 years of experience in a QMS administrator role.
• Demonstrated knowledge of medical device regulations.
• Experience as a lead internal auditor is preferred.

Responsibilities

• Coordinate A-dec’s Quality Management System in compliance with regulations.
• Manage internal audit processes and lead audit teams.
• Organize third-party audits and provide training on quality topics.

Skills

Proficient in Microsoft Office

Attention to detail

Strong technical writing

Project management

Statistical analysis

Quality measurement

Education

Bachelor’s degree in business, science, or engineering

Tools

eQMS software platforms

Job description

A-dec, Inc. in Newberg, Oregon, is seeking a Senior Quality Assurance Specialist responsible for maintaining compliance with Quality Management System (QMS) standards in the medical device sector. The successful candidate will manage internal audits, liaise with third-party inspectors, and ensure efficient business processes.

Applicants should have a Bachelor's degree and at least four years of relevant experience, demonstrating strong project management skills and a profound understanding of international medical device regulations.