Insulet Corporation Supplier Quality Manager in Billerica, Massachusetts
Oversees engineering supplier quality for the Insulet supplier base. Supports the selection, qualification, and management of external finished goods suppliers and service engineering suppliers for lnsulet. Works with manufacturers and service suppliers to ensure product / service quality meets company requirements. Interfaces with other departments (Engineering, Operations, Information Technology, and Regulatory Affairs) as well as with suppliers and other external parties on issues related to product quality. Effectively communicates Quality metrics through supplier scorecards and Management Review to the organization, suppliers, and Executive Management.
Plans, organizes, directs and reports on all engineering supplier quality-related activities such as raw materials, contracted designed and manufactured items, packaging materials, service providers, and laboratories to assure procurements meet or exceed the requirements.
Works directly with the Insulet manufacturing plant and the contract manufacturer to integrate the quality incoming performance of raw material and component supplier to collaboratively resolve issues.
Assures that customer quality-imposed technical requirements are adhered to by supplier and that a quality system is maintained
Develop procedures for supplier quality to establish world class supplier quality.
Conducts programs designed to improve supplier performance, productivity, and process validation.
Prepares, maintains and reviews procurement quality assurance procedures to assure compliance with customer and/or government requirements.
Communicates quality issues to suppliers through Supplier Corrective Action Reports as needed and provides assistance to develop corrective actions in an effort to reduce and eliminate defects.
Monitors quality control activities and systems at supplier and subcontractor facilities.
Manages and reports on supplier audit program in line with ISO GMP regulations.
Responsible for ensuring that effective up-to-date supplier Quality Assurance documentation, procedures and specifications pertaining to engineering supplier quality are maintained.
Develops reports on supplier quality performance for company management.
Liases between corporate and manufacturing sites for the deployment and communication of needs and new or improved quality requirements.
Responsible for developing and mentoring the engineering supplier quality team and growing the cGMP knowledge base .
Maintains approved supplier list and supplier history records in accordance with engineering quality system requirements.
Assists with the qualification of new suppliers, new components, and changes by developing and executing, in conjunction with other internal groups, a robust and complete set of plans and requirements for such qualifications.
Maintains accuracy of Supplier Audit Reports and Supplier Profile
Develops and maintains the Supplier Audit Schedule to ensure supplier audits are scheduled per internal procedure.
Plans and conducts scheduled audits of suppliers to assess compliance with lnsulet Requirements.
Prepares detailed trip reports and Audit Reports to document audit findings and observations
Communicates quality issues to suppliers as needed and provides assistance to develop corrective actions
Initiate and follow up on supplier corrective actions for both audit deficiencies and internal non-conformances to ensure timely closure.
Generates Monthly/Quarterly and Annual Supplier Performance Reports for Management visibility
Tracks and trends supplier performance via supplier scorecards, taking remedial action as needed
Conduct and assist with internal audits
Assist or leads CAPA evaluation and closure as related to the supplier quality processes and or supplier performance.
Participate in developmental and departmental training
Support Site during external audits (i.e. BSI, FDA, Customer).
Performs other duties as required.
BS Degree; MS of Science preferred
5-7 years of experience in quality within the medical device industry
Working knowledge of the Quality System Regulation and ISO 13485 quality system standards
Auditor training certification to ISO 13485 or other industry QMS Standard preferred
Familiarity with sampling plans
Six Sigma/Lean certification preferred
Strong verbal and written communication skills, internal and external to the company.
Good interpersonal skills in dealing with suppliers, peers and other functional areas.
The ability to prioritize multiple competing deliverables simultaneously.
Must be proficient in Word, Excel, Outlook and Power Point.
External Company Name: Insulet Corporation
External Company URL: http://www.myomnipod.com/