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Posted Apr 22Receiving Inspection Lead (Maple Plain, MN)
United StatesHybrid
Responsibilities
- Inspect materials against drawings, specifications, and quality
- 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.
- 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.
Requirements
- 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.
- 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.
- Leadership and ability to develop team members.
- Ability to manage multiple priorities in a fast-paced environment.
- Requirements: Ability to lift up to 30 pounds.
Benefits
- 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
- Compensation The anticipated base compensation range for this position is $ 60,000.00 - 90,000.00 USD annually.
- The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity.
- Compensation decisions are dependent upon the facts and circumstances of each position and candidate.
- Benefits In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Contact
- Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Additional details
- 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
- 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.
- Participate in Material Review Board (MRB) activities.
- Competences: Strong teamwork, communication, and interpersonal skills.