The Manager, Quality Assurance Engineering manages Insulet’s Supplier Quality Systems. Manage a team responsible for continuous improvements and maintenance in the Supplier Quality process, including data analytics. Stay abreast of Insulet's supplier base expansion and change, and ensure these changes are supported adequately by Insulet's QMS, particularly in the Supplier Quality area. Will work closely with stakeholders from supply chain, procurement, supplier development engineering and the factories. Also will collaborate with Regulatory and Design Assurance / Design Transfer.
Responsibilities:
- Tracking and reporting on KPI’s and supplier performance metrics.
- Tracking and reporting on internal Supplier Quality routine and improvement KPI’s and targets.
- Working closely with data analytics, integration, dashboarding teams to collect, analyze and trend data as sources of continuous improvement.
- Drive discussions and engagement around the proper maintenance and tracking of Supplier Quality records and outputs of key processes. Ensure accountability in execution of Supplier Quality Processes (supplier audits, SCARs, evaluations, ASL, etc).
- Participate on and lead teams around compliance and continuous improvement (CAPAs, Quality Plans, Greenbelt projects, etc)
- Participate in internal and external audits as a subject matter expert for Supplier Quality processes.
- Perform supplier audits as required, and participate in execution of other Supplier Quality processes (SCAR, ASL maintenance, etc).
- Owning process improvements in Supplier Quality processes, tools, and procedures.
- Participating and leading efforts to improve in the larger Supplier Management process (capacity expansions, tool qualifications, alternate vendors, external regulatory and compliance considerations).
- Stay abreast of external regulatory changes which may impact Supplier Quality QMS and assess and implement required changes.
- Drive a global perspective in the Supplier Quality processes and organization.
- Leads a team of data and process analysts in service of above.
- Suggest methods for improving product quality, design, or manufacturing processes.
- Performs other duties as assigned.
Required Qualifications:
- Bacherlor's degree.
- Minimum 5 years’ experience in an FDA regulated environment with at least 2 years of people management experience.
Preferred Skills and Competencies:
- Experience in Quality in an FDA regulated industry; experience with QSR and ISO 13485.
- Experience with FDA and ISO 13485 Certification inspections.
- Demonstrated experience managing and supervising diverse teams, preferably as a Quality Manager.
- Effective verbal and excellent technical writing skills.
- Ability to communicate at multiple levels of an organization.
- Ability to organize and judge priorities.
- Excels at generating and maintaining organized and accurate records.
- Knowledge of Engineering principles using statistics and SPC tools.
- PC skill, word processing, Excel spreadsheets and PowerBI
- Experience hosting audits (notified body, FDA, customer)
- Experience supporting Quality teams based internationally (APAC, EMEA, Americas)
- Able to work effectively in a high-stress, high-energy environment.
- Able to make effective decisions quickly based on vague or imperfect information
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $106,500.00 - $159,750.00. 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.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
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!
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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What We Do
Insulet Corporation, headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod® Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ countries around the globe.
HIRING SCAM ALERT
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If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov
