QUALITY ENGINEER, BOTHELL, WA
Andrews Cooper (AC) specializes in innovative product design and automation solutions for a variety of industries and world-class Fortune 100 companies. We partner with our clients and build long-lasting relationships based on mutual respect, trust, and goodwill.
Our commitment to our clients starts at home, with a family of over 100 talented and highly skilled engineers and staff. We believe there is a better way to operate as a company by supporting and developing our teams. Our company is passionate about what we do and how we achieve our goals:
• We are innovative and naturally curious individuals who love applying science to tough problems.
• We work as a team, from a foundation of mutual trust, humility, and integrity.
• We thrive on creating solutions, solving problems, and succeeding for our clients.
• We create a fun, safe, and collaborative environment for all to enjoy.
• We support one another with understanding and compassion through life’s difficult moments.
• We believe in doing what’s right, even when it’s not the easiest path.
• We are committed to excellence and keep our promises to deliver solutions on time and within budget.
We seek like-minded people who want to grow with us and build their careers on these principles. If you have high aspirations and thrive on challenges, dynamic projects, and enduring relationships, please read on about our current employment opportunity. If you meet our qualifications and believe in our cultural ideals, please connect with us to begin the conversation.
We continue to expand and develop our quality system to ensure our Client missions are optimized for success. The quality engineer will play a critical role in project teams and in support of our greater quality goals.
• Serve as the primary contact for all project-related quality issues from project initiation through project closeout.
• Develop, implement, and maintain the project quality plan in accordance with AC and Customer quality system requirements.
• Work with the project team to generate required quality related documents and deliverables (e.g.quality-related validation & verification planning documentation).
• Collaborate with the Client to solicit and document project requirements related to quality (i.e., 21 CFR Part 820, ISO 13485, etc.) to ensure work with AC will promote compliance with desired standards and regulatory bodies. Work to gain a common understanding with our teams and Clients by framing quality goals and the implications and potential impacts of quality related decision.
• Contribute to the work of AC design and automation teams to ensure the design and manufacturing approaches will meet the required standards for validity (i.e., quality-related 21 CFR 820 Subpart C, ISO 13485, or local standards).
• Support the development of proposals by estimating costs required to ensure compliance with the required standards or regulatory bodies.
• Work with AC operations team to continuously improve AC processes related to quality.
• Coordinate with AC management team to train and coach project team members.
• Bachelors or higher engineering degree from an accredited university
• 5+ years of relevant quality engineering experience, preferred experience in the medical products device development industry
• Experience working in an FDA regulated manufacturing and/or design environment
• Demonstrable successes in generating, monitoring adherence to, and controlling a multi-discipline quality plan, including required documentation
• Comprehensive background collaborating with project and client teams through system lifecycle (concept through rollout to manufacturing) to ensure validity and final product quality
• Expertise in generating test plans to qualify device design, and automated assembly solutions (e.g. machine tooling, R&D test equipment, diagnostic and calibration tooling)
• High level of knowledge and competence in the contents and industry best practices related to the following standards and regulations:
o 21 CFR Part 820 (and related cGxP regulations) (required)
o ISO 13485 (required)
o ISO B&C standards related to machine tool design. (not required)
o NFPA 79 (not required)
• Strong written and oral communication skills
• Experience working closely with stakeholders and maintaining healthy relationships through fast paced project cycles
• Exceptional organizational skills
• Up to 25% travel decisions required between locations
• Must possess valid US Driver’s License
• Must be legally authorized to work in the U.S. without sponsorship
• Quality Engineer Certification
Why join the Andrews Cooper team? following is a full-time position with top-tier compensation, benefits, and work positives, including:
• Competitive wages with incentive compensation
• Comprehensive medical, dental, and life insurance
• 401k Retirement savings with an automatic 3% contribution
• Engineering challenges collaborating with a varied team of A-player engineers of many disciplines
• Growth potential with an established engineering company with nearly 20 years of design excellence
• Long-term relationships and enduring partnerships
• Supportive, fun, and collaborative environment
• Andrews Cooper is an equal opportunity employer