Receiving Inspection Lead (Maple Plain, MN)

Requirements

• 3-7 years of experience in quality inspection within a medical device or regulated industry is required.
• Prior leadership or supervisory experience preferred.
• Experience with ERP systems and electronic quality systems preferred.
• Knowledge :
• Strong understanding of FDA 21 CFR Part 820 and ISO 13485 requirements.
• Ability to read and interpret engineering drawings and specifications.
• Experience with sampling plans and inspection methodologies.
• Proficiency with measurement tools such as calipers, micrometers, and vision systems.
• Competences:
• Strong teamwork, communication, and interpersonal skills.
• Leadership and ability to develop team members.
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• A demonstrated commitment to company values.
• Physical Requirements:
• Ability to lift up to 30 pounds.
• Ability to stand and perform inspection activities for extended periods.
• You. Unlimited.
• We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
• Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging. Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
• Work/Life Balance: Flexible Personal and Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: Medical, Dental, Vision, Health Savings Account with employer contribution, Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model for most professional roles
• Training: Hands On, Team Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!

Benefits

Additional Information

Life Unlimited. At Smith+Nephew we design and manufacture technology that removes the limits of life. The Receiving Inspection Lead will be a key member of Operations and will support the organization through the inspection, release, and control of incoming materials. This role ensures materials meet all quality and regulatory requirements before use in production. The ideal candidate is an action-oriented leader who can execute and oversee inspection activities with minimal oversight and thrives in a dynamic, fast-moving environment. In all actions, this person shall demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. Integrity Orthopaedics transformed soft tissue repair with a patented, FDA-cleared system designed to improve surgical fixation and long-term healing in rotator cuff repair. Now part of Smith+Nephew, we are expanding production to support a broader commercial launch and drive operational excellence across the organization. What will you be doing? Lead daily receiving inspection activities for incoming materials, components, and subassemblies. Inspect materials against drawings, specifications, and quality requirements using appropriate measurement tools. Approve or reject materials based on inspection results and ensure proper status identification and segregation. Support timely release of materials to production while maintaining compliance with all procedures. Identify, document, and support resolution of nonconforming materials in accordance with company procedures. Participate in Material Review Board (MRB) activities. Collaborate with Quality, Engineering, and Operations to resolve quality issues. Ensure all inspection documentation is complete, accurate, and audit-ready. Support internal and external audits, including FDA and notified body inspections. Train and mentor receiving inspection personnel on inspection techniques, procedures, and quality expectations. Monitor inspection performance and identify opportunities for process improvement. Maintain inspection equipment and ensure calibration status is current. Maintain a clean, organized, and compliant inspection area. Assist in other areas of the company as needed. What will you need to be successful? Education : High School diploma or equivalent required. Associate or Bachelor's degree in Engineering, Quality, or related field preferred.

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