Supplier Quality Engineer

Laborie; Minneapolis (MN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

PTO & Volunteer

Medical/Dental/Vision

HSA contributions

401k with match

Parental leave

Wellness programs

Job summary

Laborie, a world-class medical technology company, seeks a Supplier Quality Engineer to oversee supplier evaluation, risk management, and QA processes. The role emphasizes auditing suppliers, guiding CAPAs, and ensuring material quality in a fast-paced environment.

You will support product development with risk management activities and monitor supplier KPIs, requiring a minimum of 5 years in quality assurance and strong ISO 13485 knowledge.

Qualifications

• Bachelor's degree in engineering or related scientific field and at least 5 years in quality assurance.
• Knowledge of ISO 13485 and 21 CFR compliant quality systems.
• Experience with internal and external auditing.
• Experience applying statistical methods to quality assurance.
• Read and understand the Training Matrix Q620-FRM-03 or equivalent.

Responsibilities

• Identify and manage risks associated with supplied materials and maintain quality system procedures for supplier evaluation.
• Use risk management tools to identify and mitigate supplier risks and participate in supplier selection and monitoring.
• Audit current or future suppliers to ensure compliance to quality system requirements and assist with evaluation and disposition of nonconforming materials.
• Issue and provide technical direction to supplier corrective action requests and monitor and report Supplier KPI’s, Scorecards.
• Assist with quality assurance processes such as internal auditing, complaint handling, and CAPA fulfillment.
• Participate in product design and development projects and provide engineering support including risk management activities.

Skills

Quality Assurance

Auditing

Risk Management

Supplier Quality

Statistical Methods

Education

Bachelor's degree in engineering or related scientific field

Tools

ISO 13485

21 CFR quality systems

Training Matrix Q620-FRM-03

Job description

We believe that great healthcare is an essential safeguard of human dignity. A t Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you. We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

The primary emphasis of the Supplier Quality Engineer is to assist with managing product quality through the implementation of supplier/contract manufacturer evaluation procedures, use of risk management tools, and auditing of current and prospective vendors.

About the Role:

• Identify and manage the risks associated with supplied materials and maintain and implementing quality system procedures for supplier evaluation.
• Use risk management tools to identify and mitigate supplier risks and participate in the supplier selection and monitoring process.
• Audit current or future suppliers to ensure their compliance to quality system requirements & material specifications and assist with the evaluation and disposition of nonconforming materials.
• Issue and provide technical direction to supplier corrective action requests and monitor and compile reports for Supplier KPI’s, Scorecards.
• Assist with quality assurance processes such as internal auditing, complaint handling, and CAPA fulfillment.
• Participate in product design and development projects as needed and provide engineering support to products including risk management activities.

Minimum Qualifications:

• Bachelors' degree in an engineering or related scientific field and a minimum of 5 years of experience in quality assurance.
• Knowledge of ISO 13485 and 21CFR compliant quality systems.
• Experience with internal and external auditing.
• Experience applying statistical methods to quality assurance.
• Required to read and understand the following documents:
  • Refer to the current version of the Training Matrix Q620-FRM-03 or equivalent

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law.

Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.