The Role
Manages supplier and contract manufacturer quality through risk assessment, qualification, monitoring, and audits. Evaluates supplier compliance with quality systems and material specifications, handles nonconforming materials, issues corrective action requests, tracks supplier KPIs and scorecards, and supports internal audits, complaint handling, CAPA, product development, and product risk management.
Summary Generated by Built In
We believe that great healthcare is an essential safeguard of human dignity.
At 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.
Skills Required
- Bachelor's degree in engineering or a related scientific field
- Minimum of 5 years of experience 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
- Ability to read and understand the current Training Matrix Q620-FRM-03 or equivalent
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The Company
What We Do
Laborie develops innovative medical technologies – including diagnostic equipment and consumable supplies – in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. LABORIE is comprised of a variety of powerful brands – cultivated over more than 50 years of providing innovative products and services to our customers. Our story is one of continuous profitable growth, driven both organically and inorganically through mergers and acquisitions. We are privately owned by Patricia Industries and a part of the Investor AB network. Our owners take a long-term investment approach and create value for people and society by building strong and sustainable businesses. We know the work we do at LABORIE matters – we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.
