Oxford Immunotec is seeking a highly motivated and self-directed leader to join a cohesive Quality Assurance team in a high-volume clinical diagnostic laboratory. The successful candidate will be responsible for providing Quality guidance to the lab operations team, ensuring the lab is compliant with relevant standards and regulations from CAP, CLIA, and states, and ensuring the Quality Management System is effective. In addition, the successful candidate will develop and oversee a team of dedicated Quality professionals.
Elevate the Quality profile of the organization by engaging in meaningful dialogue with Operational partners
Serve our patients and clients by ensuring we provide test results of the highest quality and reliability
Provide support and oversight to the Quality team in such tasks as
Release of incoming and manufactured goods
Internal and supplier audits
New hire induction
Training and Competency oversight
Host inspections by regulating and accrediting bodies
Create and report relevant quality metrics
Collaborate with cross-functional teams in the development of new products and services
Contribute to the organizational mission by partnering with other leaders and supporting them in their objectives
Biological Sciences (or related) degree
7+ years Quality experience, preferably in laboratory or IVD/medical device environment with 3 years of supervisory experience
ASQ Certified Quality Auditor (CQA), with experience performing internal and external audits
Experienced in working to GXP and a good knowledge of Quality Management principles
Strong attention to detail and Quality commitment
High standards of mathematics, writing ability and oral communication
Conscientious, thrives in high pressure work, and demonstrates strong initiative
Understanding of the scientific, biological and technical issues involved in developing diagnostic assays
Proficient in MS Office products
The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Minimal travel required including international travel.
Internal Number: 2018-1950
About Oxford Immunotec
At Oxford Immunotec, we believe the key to building an exceptional company begins with exceptional people. And as a high-growth, post-IPO healthcare company, we’re proud to see that belief transformed into action every day.
Across the globe, Oxford Immunotec is driven by the expectation of excellence. Our proprietary immunology platform is already generating a major impact on human life by creating more effective ways to test for diseases like TB and transforming the diagnostics marketplace in the process. At the same time, we are setting a new standard for careers with our commitment to giving passionate and creative people the freedom to realize their full potential.
At Oxford Immunotec, you’ll find great science driven by intellect, curiosity, and the humility to learn from your setbacks. Every day, we create personal opportunity driven by innovation and extraordinary growth. And, at the heart of it all, you’ll find great people united by the joy of doing important work…and being valued for it. Help drive our future success and join the team at Oxford Immunotec.