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Quality Coordinator

Department: Quality & Operational Excellence

Location: Burlingame, California, United States

Title: Quality Coordinator


About the role:

As a quality assurance coordinator, the job responsibilities include assisting quality system management including: complaints, non-conformances (NCs), corrective and preventive actions (CAPAs), document change controls etc. The job responsibilities also include supporting and coordinating the medical device real time stability program

Essential Responsibilities:

• Participate or lead investigations as part of NCs, and CAPAs.
• Participate or lead root cause analyses.
• Perform risk analyses.
• Initiate, contribute to, and execute quality plans.
• Participate in and support both internal and regulatory audits.
• Quality-minded approach to all work.
• Implement good documentation practices.
• Comply with all quality and safety standards.
• Coordinate with manufacturing to execute real time stability testing for every medical device production lot.
• Contribute to a healthy and safe working environment by adhering to health and safety regulations and company policies.
• Act in a responsible manner to ensure the care of their own health and safety and where appropriate, their team and that of others who may be affected by their omissions at work.

Minimum Qualifications:

• HS diploma/GED
• Experience working in quality management system harmonized with FDA 21 CFR Part 820, ISO 13485, MEDDEV 2.12-1, Canadian Medical Device Regulation SOR/98-282.

Desired Qualifications:

• College degree (or in-process) highly preferred.
• Experience with regulatory audits desirable.
• Strong PC skills required; proficient in Microsoft Office.
• Exceptional communication skills (both oral and written).
• Proven ability to problem solve, multi-task and take initiative.
• Capacity to learn new information both general and technical.
• High attention to detail and accuracy.
• Experience completing immunoassays with preference towards immunohistochemistry.

About Us

Ever since 1998, when our founder, Jonathan Milner, started selling antibodies from the back of his bike, Abcam has aimed to help scientific researchers make breakthroughs faster. We now have offices and labs in the UK, the US, China and Japan, and as we continue to grow, we remain ambitious, driven by our customers’ success and their research needs.

It’s our goal to provide a world-standard in protein research tools, technical support and delivery. When you join Abcam, you’ll join a global business with the passion and the vision to become the most influential company, and, best-loved brand in life sciences.

Our culture is our key differentiator. We believe in empowering individuals, with responsibility given at an early stage. The working environment is fun and fast-paced, collaborative and outcome focused, with a strong customer focus. In addition to competitive salaries, we can offer an attractive flexible benefits package which includes share options, a culture focused on well-being and opportunities for growth and development.

Abcam is an Equal Opportunity Employer and makes all employment decisions without regard to age, national origin, race, ethnicity, religion, creed, gender, sexual orientation, disability, veteran status, or any other characteristic protected by law.