Laborie

Quality Engineer II

Laborie  •  Plymouth, MN (Onsite)  •  3 months ago
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Job Description

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:As a key member of the Quality team, the  Quality Engineer is responsible for ensuring that the technical regulatory and quality requirements are met for products throughout their product life cycle. This role focuses on quality system maintenance, process improvements, and supporting production operations.   About the Role: 
  • Develop and execute quality plans and protocols for product and process validations.
  • Conduct root cause analysis and implement corrective and preventative actions (CAPA) and participates in projects/CAPA teams of moderate complexity.
  • Review and approve change control requests to ensure compliance, support supplier qualification activities and monitor supplier performance, and support risk management.
  • Perform risk assessments, including Failure Modes and Effects Analysis (FMEA), participate in internal and external audits, and collaborate with cross-functional teams on product development and process improvements.
  • Develop simple to moderate protocols, procedural updates, identifies inspection process improvements. 
 Minimum Qualifications:
  • 2+ years' experience in Quality Engineering with technical bachelor's degree or equivalent work experience
  • Previous medical device industry experience preferred
  • Knowledge of quality tools and methodologies (Six Sigma, SPC, etc.)
  • Familiarity with quality standards and regulations (ISO 13485, FDA 21, CFR Part 820)
  • Proficiency in data analysis and statistical tools
 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
  • 401k Retirement Plan with Company Match
  • Parental Leave and Adoption Services
  • Health and Wellness Programs and Events
  • Awarded 2024 Cigna Healthy Workforce Designation Gold Level
 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.
Laborie

About Laborie

Laborie is a world-class specialist medical company that makes and advances technologies that preserve and restore human dignity. We take great pride in supporting doctors, nurses, hospitals, clinics, academic institutions and patients with treatment and diagnostic innovations. Our technologies include diagnostic equipment and consumable supplies in the Urology, Gastroenterology, Gynecology, Obstetrics and Neonatology fields.

Privately owned by Patricia Industries and a part of the Investor AB network, Laborie is comprised of powerful brands that have been cultivated for more than 50 years. As a rapidly growing and scaling organization, our company values drive our day-to-day behaviors and make us ONE Laborie whenever and wherever we do business. We know that the work we do matters and we’re making a positive impact in the lives of patients across the globe. This is what fuels our motivation each day.

If you’re ready to be part of a mission with meaning and a rewarding environment with opportunities for professional growth and career advancement, view our current job openings at https://www.laborie.com/about-us/careers/

Industry
Unknown
Company Size
501-1,000 employees
Headquarters
Portsmouth, New Hampshire
Year Founded
1967
Website
laborie.com
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