Manager, Supplier Quality Systems (Hybrid - Acton, MA.)

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 simpli