QA Group Leader: Medical Device Testing

Company Description Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies.

In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the  over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing.

Job Description Employee Responsibilities:

Delegate responsibilities and project ownership to direct reports. Provide follow-up, support, and constructive feedback for delegated tasks.

Make employee development a top priority – project/department cross training, technical skills development, involvement/ownership, job plans in place, expectations/goals clearly communicated.  Be available and coach direct reports though challenges, without doing the work for them.  Provide direct reports with constructive, positive feedback for continuous improvement and development.  Provide real-time feedback. Interact with and/or educate other departments (technical and support) to ensure that Eurofins, as an organization, is providing quality data in a timely manner that meets the clients needs.

Demonstrate professional behavior and support upper management in initiatives to improve quality/productivity.  Work with the laboratory and support groups to improve quality metrics, and enable CAPA implementation.  Also support the technical and supports groups with investigation writing and review, including thorough root cause analysis

Technical writing and review; tracking action items and driving to completion; ability to identify trends in recurring events.

Demonstrate leadership qualities such as: effective communication, display of confidence, motivation, and follow through on assignments.

Perform higher level QA tasks including but not limited to: major investigation writing/review, in-depth root cause analysis, data trending/analysis, supplier audits, internal audits, validation/change control writing/review, batch record/EM report review, assist with agency inspections, review/write QAU procedures.

Qualifications The ideal candidate would possess:

Familiarity with GMP and Medical Device Quality System (21 CFR Part 820 and ISO 13485)
Knowledge of general requirements for the competence of testing and calibration laboratories (ISO/IEC 17025)
Experience in handling/supporting external audits (agency and client)
Strong computer, scientific, and organizational skills

Ability to Multi-task and to make decisions when required.

Excellent communication (oral and written) and attention to detail

Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Strong leadership, initiative, and team building skills

Basic

Minimum…