Quality Engineer 2

Smith & Nephew; Maple Plain (MN); Hybride; USD 74 000 - 112 000; Plein temps

Avantages offerts par ce poste

Health, dental, vision insurance

401(k) matching

Tuition reimbursement

Flexible time off

Résumé du poste

Smith+Nephew in Maple Plain, MN is seeking a Quality Engineer II to own and drive manufacturing quality objectives, including product performance, process control, and compliance. You will lead investigations into quality events, develop CAPAs, and provide hands-on support for sterile packaging and sterilization.

The role partners with multiple functions to ensure quality is embedded in new and expanding manufacturing lines, with emphasis on problem solving and lean quality principles.

Qualifications

• Experience leading investigations or corrective actions in medical devices or regulated manufacturing.
• Knowledge of inspection methods, engineering drawings, measurement tools, sampling plans, quality documentation, and manufacturing process controls.
• Ability to lift up to 20 pounds and work with limited supervision.

Responsabilités

• Own and execute manufacturing quality objectives focused on product performance, process control, compliance, and scalability.
• Lead investigations into manufacturing and product quality events, including nonconformances, process issues, material discrepancies, and customer complaints, developing effective corrective and preventive actions.
• Provide hands on quality support for manufacturing processes, including sterile packaging and sterilization activities.
• Lead defined cross functional quality and continuous improvement projects, applying practical problem solving and lean quality principles.
• Partner with Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to integrate quality requirements into new and expanding manufacturing lines.
• Monitor supplier and incoming material quality performance and support supplier corrective actions.

Connaissances

Quality engineering

Investigations leadership

Communication skills

Cross-functional collaboration

Regulatory knowledge

Formation

Bachelor's degree in Engineering

Description du poste

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.Join Integrity Orthopaedics, now part of Smith+Nephew, as a Quality Engineer II in Maple Plain, Minnesota. This is an exciting opportunity to bring your quality engineering expertise to a growing medical device manufacturing operation, taking ownership of key quality activities while partnering across engineering, manufacturing, purchasing, and quality teams.What will you be doing?Independently own and execute manufacturing quality objectives focused on product performance, process control, compliance, and scalability.Lead investigations into manufacturing and product quality events, including nonconformances, process issues, material discrepancies, and customer complaints, developing effective corrective and preventive actions.Provide hands on quality support for manufacturing processes, including sterile packaging and sterilization activities.Lead defined cross functional quality and continuous improvement projects, applying practical problem solving and lean quality principles.Partner with Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to integrate quality requirements into new and expanding manufacturing lines.Monitor supplier and incoming material quality performance and support supplier corrective actions.Apply inspection methods, engineering drawings and specifications, measurement tools, sampling plans, and nonconforming material controls.Provide technical guidance and training support to less experienced team members and inspection personnel.Maintain clear, accurate, and timely quality records while supporting compliance with applicable regulatory requirements.What will you need to be successful?A bachelor's degree with at least 2 years of related work experience , or an equivalent combination of education and experience. A four year engineering degree is preferred.Experience independently leading investigations, improvement activities, or corrective action projects within medical devices or another regulated manufacturing environment.Working knowledge of inspection methods, engineering drawings, measurement tools, sampling plans, quality documentation, and manufacturing process controls.Experience across multiple manufacturing quality functions is preferred, particularly receiving inspection, incoming quality control, supplier quality, sterile packaging, sterilization, and process validation.Strong written and verbal communication skills, with the ability to work independently with limited supervision and provide technical guidance to others. The role requires the ability to lift up to 20 pounds.Before applying, please note that this position is not eligible for employer-sponsored immigration support. Applicants must be currently authorized to work in the United States and must not require S+N sponsorship now or in the future to maintain that authorization .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.Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition ReimbursementWork/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service DayYour Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance ProgramFlexibility: Hybrid Work Model (For most professional roles)Training: Hands-On, Team-Customized, MentorshipExtra Perks: Discounts on fitness clubs, travel and more!The anticipated base compensation range for this position is 74,250.00 - 111,500.00 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.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.Stay connected by joining our Talent Community .We're more than just a company - we're a community! Follow us on L inkedIn to see how we support and empower our employees and patients every day.Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You . Unlimited . , life, culture, and benefits at S+N.Explore our website and learn more about our mission, our team, and the opportunities we offer.