The OneSource Quality Assurance Manager will be responsible for maintaining the Quality Management System (QMS) for the OneSource Enterprise Global Business Unit within PerkinElmer. The role will work closely with the senior leadership team across the business unit and company to ensure QMS compliance and deliver on key Quality metrics. The ideal candidate has deep expertise in quality assurance for technical and non-technical customer support teams and has experience managing at a global scale.
Responsibilities
Ensure effectiveness and compliance to ISO 9001:2015 QMS as the Global OneSource Enterprise Quality Management Representative.
The Quality Manager will partner with and support leadership to construct a Quality program to ensure the organization delivers an exceptional customer experience.
Ensure consistent lab service quality across global accounts to drive overall customer satisfaction.
Liaison between customer accounts and OneSource team for service quality feedback.
Chair quality management reviews and manage internal & external audits.
Provide advice and support to the service account owners on quality issues/initiatives.
Evaluate and support quality agreement evaluations, supplier approval review, equipment calibration records, CAPAs, complaint investigations, document change control, and LMS training compliance.
Active and engaged member of the OneSource Senior Leadership Team.
Generate Quality metrics and report findings to SLT in a timely fashion.
Educate internal teams on quality processes, standards, and results.
Support and implement global quality system process integration, harmonization, and simplification.
Represent the Quality Team in meetings.
Work cross-functionally to achieve OneSource and PerkinElmer objectives.
Lead or support identified special projects and key initiatives as needed.
Basic Qualifications
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.
Role is on site in Shelton, CT and does not have a budget for sponsorship at this time.
Preferred Characteristics
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.
Proficiency in SAP, ServiceMax, SharePoint, Microsoft Excel, Word, and PowerPoint.
The annualcompensation range for this full-time position is $111,280.00 to $167,44000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.
