Sr. Manager, Quality Operations (Onsite)
About The Position
Join Insulet as a Senior Manager, Quality Control and play a key leadership role in ensuring the quality and compliance of life-changing medical devices. In this highly visible position, you will lead QC operations, oversee laboratory testing, validation, environmental monitoring, and compliance programs, while developing and mentoring a talented team in a fast-paced, highly automated manufacturing environment. This is an excellent opportunity for an experienced Quality professional to drive continuous improvement, support regulatory inspections, collaborate across departments, and make a direct impact on patients worldwide as Insulet continues its rapid growth and global expansion.
Requirements
- BS degree in scientific discipline; and/or equivalent combination of education and experience
- Minimum of 10+ years’ experience of relevant experience in Quality Control / Quality Assurance
- Minimum 2+ years’ managerial experience in a manufacturing environment
- Must possess strong leadership, analytical and communication skills with team-focused attitude
- Experience leading or supporting FDA and ISO 13485 inspections preferred
- Excellent interpersonal, verbal and written communication skills
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to communicate and work effectively at multiple levels within the organization
- Advanced PC skill, word processing, spreadsheet, and database
- Highly proficient with industry standards sampling plans (ANSI z1.4 & z1.9)
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
- Experience working in a highly automated/high volume manufacturing environment
- Support staff working in a 24/7 operation
- Ability to lift up to 30 lbs.
- Frequently standing, walking, reaching above shoulders and below waist.
Responsibilities
- Manages various QC program(s)/processes within the department (training, sample management, data review and reporting) and serves as subject matter expert (SME).
- Coordinates and facilities QC activities to meet commitments on-time
- Ensure QC personnel have appropriate training.
- Leads planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification
- Assist in troubleshooting of test methods and/or equipment as required
- Authors, review, and/or approves data, SOPs, COAs, and DHRs
- Monitor, track and publish QC metrics
- Ensure all QC records and DHR documentation adhere to cGMP/GDP expectations
- Leads compliance related teams working towards the goal of continuous improvement
- May be required to lead NCMR, OOT investigations/deviations and to identify corrective actions to prevent reoccurrence
- Serves as QC representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all QC needs
- Participates in internal and external quality audits
- Recruits, coaches, and develops organizational talent
- Perform other duties as assigned
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- Additional employee wellness programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
