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!
The Team Lead for Post Market Receiving & Inspection plays an integral part of Insulet's Quality Department as a hands-on leader working with FDA approved medical devices. The role requires strong organizational skills and attention to detail while working in cross functional teams to accomplish departmental and company goals.
Responsibilities:

• Provide work leadership/mentorship to team members, including training support on processes and procedures.
• Perform tasks to ensure compliance with quality standards.
• Track daily team metrics to ensure performance targets are achieved.
• Lead the Post Market receiving team on return sample receiving and handling.
• Ensure effective processes are implemented and maintained.
• Develop and update protocols and standards to meet quality specifications and recommend procedural changes.
• Lead and perform product inspection including troubleshooting and failure analysis.
• Review applicable DHR's, NCMR's, CAPA's, and deviations associated with individual complaints.
• Manages, facilitates, and participates in Continuous Improvement projects.
• Review / Sign-off work of Post Market team members.
• Assist in cross-functional special projects.
• Performs other duties as assigned.

Minimum Requirements:

• BS/BA degree preferably in a technical discipline (Business, Operations, Engineering, or Science) or equivalent experience (minimum of 4 years).
• Minimum 2 years of supervisory experience, preferably in an ISO 9001, ISO 13485, and/or FDA regulated environment.

Preferred Skills and Competencies:

• Preferred 1 year of experience working with medical device quality system requirements (21CFR Part 820, ISO 13485)
• Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work.
• General knowledge of performance metrics
• Effective verbal communication and writing skills.
• Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision.
• Prior experience working in a regulated industry (medical device) and/or experience working in a biohazard/lab environment preferred.
• Experience creating and analyzing charts and Pareto charts in MS Excel a plus.
• Experience or certification in Lean Six Sigma, SPC, ASQ, and/or ISO process controls.
• Excels at generating and maintaining organized and accurate records.
• Complaint management software skills. (i.e. Salesforce, Trackwise, PLM, etc.)

Physical Requirements (if applicable):

• Sitting 70%, Standing 30%
• Frequent lifting <5lbs
• Occasional (<5% of time) handling (push/pull) up to 50lbs
• Ability to operate basic hand tools

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 $24.95 - $37.50. 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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