Quality Engineer

Job Description

We are looking for a hands-on Quality Engineer to support and improve quality systems within a regulated manufacturing environment. This person will own CAPAs, investigations, process controls, validations, risk management, and quality data, while partnering closely with Manufacturing, Engineering, and Operations. The ideal candidate has personally implemented or improved quality processes, can investigate problems from root cause through corrective action, and can speak in detail about the work they have owned.

Compensation: $110-130k. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.

Skills and Requirements

1. CAPA + Investigations

3+ years Quality Engineering experience

Hands-on ownership of CAPAs and nonconformance investigations

Strong root cause analysis

Able to take corrective actions through implementation and effectiveness checks

1. Process Controls + Quality Systems

Experience in regulated manufacturing, ideally medical device

ISO 13485 / FDA quality system experience

Process controls, process definition, and quality data

Must have personally implemented, changed, or improved a quality process

1. Validation + Risk

Experience with IQ/OQ/PQ and process validation

Risk management / FMEA

Comfortable analyzing quality trends and manufacturing issues

Able to work directly with Manufacturing and Engineering to improve processes Medical device experience

ISO 14971 / Risk Management

NPI / design transfer experience

SPC / MSA / Minitab

Lean / Six Sigma

Cleanroom experience

ASQ Certified Quality Engineer (CQE)

Audit experience

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to View email address on click.appcast.io.