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QA Group Leader: Medical Device Testing @ Eurofins

Lancaster, PA, usOnsiteFull-timePosted 34 days ago

Opens on smartrecruiters

About this role

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 analysisTechnical 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 skillsAbility to Multi-task and to make decisions when required.Excellent communication (oral and written) and attention to detailAbility to work independently and as part of a team, self-motivation, adaptability, and a positive attitudeAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policiesStrong leadership, initiative, and team building skillsBasic 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 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

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Skills

Quality AssuranceScienceMid-Senior LevelBiotechnology

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