TITLE: Quality Engineer

LOCATION: Kirkland, WA (on-site)

EMPLOYMENT TYPE: Direct-Hire

PAY RANGE: $100K - $120K

*Exact compensation may vary based on skills, experience, and location.

BENEFITS:

• Medical/Dental/Vision
• FSA
• 401K match
• PTO
• Life & Disability Insurance

ROLE & RESPONSIBILITIES:

We are seeking a Quality Engineer who will be responsible for supplier quality, risk assessment, incoming, in-process, and final inspection processes, product and process verifications and validations, complaint investigations, statistical methods, non-conforming material investigation/disposition, and corrective actions

• Perform failure investigations, including root cause analysis, for nonconforming products and devices returned from the field
• Perform internal audits in accordance with the established audit schedule
• Evaluate, qualify, monitor, audit, and coordinate quality-related activities with suppliers.
• Develop, implement, monitor, and improve inspection methods, including receiving inspection, sub-assembly, and final assembly
• Evaluate, design, and implement fixtures, tooling, methods, and equipment necessary to support QA inspection and testing
• Develop and evaluate quality metrics and trends related to performance of the quality system, and identify improvement opportunities
• Apply appropriate statistical controls to product test and inspection processes
• Support manufacturing and design/ development activity, including product and process validations, qualifications, and verifications
• Represent the Quality Assurance function for evaluation/qualification of product and process change
• Perform corrective and preventative action investigations and closures
• Perform other responsibilities in support of compliance and manufacturing as required

ESSENTIAL QUALIFICATIONS:

• Bachelor's degree in an engineering discipline or related science required. ASQ Certified Quality Engineer preferred.
• 3+ years of experience in quality engineering.
• Experience in the medical device industry (preferred) or a similar biotechnology industry
• Experience with failure investigations, root cause analysis, corrective/preventative actions, report writing and trend analysis
• Understanding of medical device quality system regulations and standards (e.g., ISO 13485, ISO 14971)
• Experience supporting notified body and/or FDA audits
• Experience planning, conducting, and documenting process I product validations
• Experience conducting internal and supplier audits.
• Knowledge of quality tools and methods, including SPC, six sigma, design of experiments, sampling plans and statistical analysis using programs such as JMP or Mini tab
• Integration of customer requirements and specification development
• Properties and processing of materials used in implantable and invasive medical devices, including metals, polymers, and packaging

WHY AVERRO?

Averro is a Veteran-Owned organization dedicated to delivering innovative talent solutions, business consulting and technology services that propel businesses and careers forward. We live by our ethos: Be Curious | Build Trust | Empower Each Other. These values show in our commitment to client satisfaction, timely support, unmatched consultant care. Our Aim – Your Ascent.

Averro is an equal opportunity employer , and we are committed to diversity, equity, and inclusion in the workplace. All qualified applicants will receive consideration for employment, regardless of criminal histories, consistent with legal obligations. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

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