Qualitty Inspection Lead

Smith & Nephew - USA

Maple Plain, MN

JOB DETAILS
SALARY
$60,000–$90,000 Per Year
SKILLS
Calibration, Code of Federal Regulations, Communication Skills, Detail Oriented, Equipment Maintenance/Repair, External Audit, FDA (Food and Drug Administration), FDA Requirements, Fitness, ISO (International Organization for Standardization), Internal Audit, Interpersonal Skills, Leadership, Maintain Compliance, Medical Equipment, Mentoring, Multitasking, Operational Support, Organizational Skills, Orthopedics, Patient Safety, Performance Analysis, Problem Solving Skills, Process Improvement, Product Safety, Production Support, Quality Control, Quality Engineering, Receiving Inspection, Regulatory Requirements, Sampling Inspection, Stock Purchase Plans, Support Documentation, Team Player, Time Management
LOCATION
Maple Plain, MN
POSTED
12 days ago

The Quality 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.

Experience:

  • 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!

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. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. 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

You should be proficient in:

  • Quality Inspection Experience
  • FDA Regulations
  • ERP & MRP Systems

About the Company

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Smith & Nephew - USA

The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business. Thomas James Smith black and white photograph Image: Thomas James Smith A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months. By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments. In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics — which offered high growth and margin opportunities. Smith & Nephew was incorporated and listed on the London Stock Exchange in 1937 and in 1999 the Group was also listed on the New York Stock Exchange. In 2001, Smith & Nephew became a constituent member of the FTSE-100 index in the UK. This means that Smith & Nephew is included in the top 100 companies traded on the London Stock Exchange measured in terms of market capitalisation. Today, Smith & Nephew is a public limited company incorporated and headquartered in the UK and doing business in many countries around the world.
COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Medical Devices and Supplies