Quality Engineering Manager, USA Manufacturing(On-site)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
Reporting directly to the Director of Quality Operations, the Quality Engineering Manager, USA Manufacturing provides oversight of a variety of analytical functions that occur in the QE department supporting validation, testing, process control, failure investigation, and disposition. Partnering with project and production teams, supports new product and process introductions. This role also ensures full compliance of the site Quality System with US FDA, ISO 13485, and other applicable country-specific regulatory requirements. The role will have formal people management responsibilities.
Responsibilities
• Manages various QE program(s)/processes within the department and serves as subject matter expert (SME) in Quality Engineering related topics.
• Leads and supports planning, coordination and/or review of test method validations, test method transfers and/or equipment qualification/requalification, as required.
• Assist in troubleshooting of test methods and/or equipment as required.
• Authors, review, and/or approves data, SOPs, COAs, DHRs and other documents as needed.
• Monitor, track publish and report QE metrics at the Operations and Quality meetings (MRB, etc). As necessary analyze metrics to identify trends and actions to correct adverse trends.
• Supports activities ensuring all records and DHR documentation adhere to cGMP/GDP expectations and product release occurs in timely manner.
• Leads compliance related teams working towards the goal of continuous improvement.
• Partners with Post Market team in complaint investigations.
• May lead NCMR, OOT investigations/deviations and identify corrective actions to prevent reoccurrence.
• Often serves as Quality representative in cross-functional, cross-departmental working teams and CAPAs.
• Participates in internal and external quality audits.
• Manage team of Quality Engineering professionals to ensure development, alignment, and performance. Ensure QE personnel have appropriate training and competency.
• Recruits, coaches, and develops organizational talent.
Key Decision Rights
• Leads cross functional discussions around nonconforming products and processes.
• Drives and supports prioritization of QE resources in service of strategic goals and targets.
• Identifies areas for continuous improvement.
Required Leadership/Interpersonal Skills & Behaviors
• Collaborate and drive improvement cross-functionally.
• Identify and drive continuous improvement opportunities.
• Align with the larger strategic goals and objectives, and track progress to targets.
• Lead and develop a team of quality professionals in fast paced environment.
Required Skills and Competencies
• Ability to make risk based decisions in concert with others, and according to established QMS processes.
• Excellent communication skills and the ability to work collaboratively with cross-functional teams.
• Deep experience in Quality Engineering practices such as statistics, risk management, failure investigation.
• Strong analytical skills and the ability to interpret complex data.
Education and Experience
• BS degree in scientific discipline; and/or equivalent combination of education and experience.
• Minimum of 6 years' experience of relevant experience in Quality Engineering, with particular focus in Factory / Operations Quality. Ideal experience would be in high-volume electromechanical devices.
• Minimum 2 years' experience in Operations Quality Management.
• Must possess strong leadership and analytical skills with team-focused attitude.
• Experience leading or supporting FDA and ISO 13485 inspections preferred.
• Intermediate to advanced skill level of MS Word, Excel, Access, Minitab, Auto Cad or equivalent.
Additional Information
• The position is in person at our Acton, MA USA flagship manufacturing facility.
• Travel is estimated at 5% but will flex depending on business need.
NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite
Additional Information:
The US base salary range for this full-time position is $99,600.00 - $149,700.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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