Manager - Lab Services, Sterility Assurance

Job Title

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the :

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values :

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description :

Plans, directs and coordinates the operational activities of a multi-faceted Sterility Assurance laboratory with method development / validation projects and routine SOP / compendia driven analyses.

Has personnel, quality and performance responsibility for department with annual sales of approximately $3 million.

Maintains qualified staff by recruiting, selecting, training, and mentoring Associates.

Confirms quality systems are applied in the performance and documentation of laboratory studies.

Meets client's expectations for timeliness of laboratory studies as measured by on-time percentage.

Accomplishes financial objectives by forecasting requirements / capacity, provides annual capital estimates and expense budgets, scheduling expenditures, analyzing variances, and initiating corrective actions if necessary.

Establishes department goals by gathering pertinent business, financial, service, and operations information, identifying and evaluating trends and options, choosing a course of action, defining objectives and evaluating outcomes.

Keeps abreast of new technologies relating to sterility assurance and applies these technologies to the laboratory as necessary.

Drives new test developments relating to Sterility Assurance testing.

Works directly with the Director of QC & Sterility Assurance to determine long-term goals and projections of Quality Control and Sterility Assurance testing laboratories.

Qualifications & Technical Competencies :

Requires a Bachelor's degree in Microbiology or Microbiology related discipline (Masters or PhD preferred).

Requires 8-10 years of related work experience including 5 years supervisory experience.

Regulatory Interface and P&L experience required.

Fluency in English and local language, if different, required.

Thorough knowledge of, but not limited to, FDA, DEA, OSHA and local health agency standards / regulations

Working Conditions :

Physical activities include walking, sitting and standing for prolonged periods and operating laboratory equipment.

Extensive use of computer keyboard and mouse.