QA Group Leader: Medical Device Testing

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.

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 Qualifications

• Bachelor's degree in Science or Engineering with a minimum of 2 years experience in the laboratory or a minimum of 4 years of experience in the laboratory at a high level of performance (if possessing no degree)
• Experience in regulated industries (Medical Device, Pharmaceuticals,)
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

Position is Full-Time, Monday-Friday, 8:00 a.m.-5:00 p.m., with additional hours, as needed. Candidates currently living in a commutable distance to Lancaster, PA are encouraged to apply.

What we Offer

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays