Quality Assurance Manager
2 weeks ago
PerkinElmer is seeking a highly experienced Quality Assurance Manager to join our OneSource Enterprise Global Business Unit. As a key member of our senior leadership team, you will be responsible for maintaining the Quality Management System (QMS) and ensuring compliance with ISO 9001:2015 standards.
Key Responsibilities:- Develop and implement quality management processes to ensure consistent lab service quality across global accounts.
- Partner with leadership to construct a quality program that delivers an exceptional customer experience.
- Liaise between customer accounts and OneSource teams for service quality feedback.
- Chair quality management reviews and manage internal and external audits.
- Provide advice and support to service account owners on quality issues and initiatives.
- Evaluate and support quality agreement evaluations, supplier approval reviews, equipment calibration records, CAPAs, complaint investigations, document change control, and LMS training compliance.
- Generate quality metrics and report findings to the senior leadership team in a timely fashion.
- Bachelor's degree in a relevant field.
- 5+ years of experience managing Quality Management Systems within the medical device or pharmaceutical industry or under an ISO 13485:2016 or ISO 9001:2015 QMS.
- 3+ years of management experience.
- Knowledge of regulatory requirements and standards relevant to manufacturing, such as ISO45001/OHSAS18001 and ISO14001.
- Strong customer focus with complaint investigation, significant event reporting, and CAPA skills.
- Must communicate fluently in English.
- Internal Auditor certification.
- Strong data analysis skills and proficiency in electronic data management systems.
- Good understanding of quality management systems and tools such as PPAP, FMEA, and SPC.
- Ability to work independently and collaborate effectively with cross-functional teams.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law.
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