Quality Engineer 2

Smith & Nephew, Inc.; United States; Presencial; USD 74 000 - 112 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401k Matching

Discounted Stock Purchase Plan

Tuition Reimbursement

Hybrid work model

Resumo da oferta

Smith+Neuwe is seeking a Quality Engineer II in Maple Plain, Minnesota, to own key quality objectives, lead investigations, and support sterile packaging and sterilization processes. You will partner across engineering, manufacturing, purchasing, and quality teams to ensure product quality and process control.

The successful candidate will have a bachelor’s degree in engineering with 2+ years in medical device or regulated manufacturing environments, strong communication skills, and the ability

Qualificações

• Bachelor's degree with 2+ years of related work experience; a four-year engineering degree is preferred.
• Experience independently leading investigations, improvement activities or corrective action projects in medical devices or regulated manufacturing.
• Working knowledge of inspection methods, drawings, measurement tools, sampling plans, quality documentation, and process controls.
• Experience across multiple manufacturing quality functions (receiving inspection, incoming quality, supplier quality, sterile packaging, sterilization, process validation).
• Strong written and verbal communication; ability to work independently and lift up to 20 pounds.

Responsabilidades

• Own and execute manufacturing quality objectives focused on product performance, process control, compliance, and scalability.
• Lead investigations into manufacturing and product quality events and develop effective CAPAs.
• Provide hands-on quality support for manufacturing processes including sterile packaging and sterilization.
• Lead cross-functional quality and continuous improvement projects using lean quality principles.
• Partner with Manufacturing Engineering, Process Development, R&D, Purchasing, and Quality to integrate quality requirements.
• Monitor supplier and incoming material quality performance and support supplier corrective actions.
• Apply inspection methods, drawings and specifications, measurement tools, sampling plans, and nonconforming material controls.
• Provide technical guidance and training to junior team members and inspection personnel.
• Maintain accurate quality records and support regulatory compliance.

Conhecimentos

Quality engineering

Investigations leadership

Communication skills

Independent work

Formação académica

Bachelor's degree in engineering

Ferramentas

Engineering drawings

Measurement tools

Descrição da oferta de emprego

Life. Unlimited. At Smith+Neuwe we design and manufacture technology that takes the limits off living.

Join Integrity Orthopaedics, now part of Smith+Neuwe, 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 Reimbursement
Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), 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!

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+Neuwe 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.