The Role
Ensures conformity of medical device products and processes with quality systems, regulatory standards, and customer requirements. Responsibilities include managing inspection and release documentation, supporting audits and validations, investigating nonconformities and complaints, maintaining calibration records, supporting engineering changes and CAPA activities, analyzing quality data, and contributing to risk assessments and Material Review Board decisions.
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 Quality Engineer II ensures product and process conformity to requirements. Ensuring documentation in conformance to the Quality Management Systems and applicable standards and regulations.
About the Role:
- Establish and maintain documentation for the inspection and release of raw materials, sub-assemblies and finished medical devices
- Perform quality activities in support of Operations, contract manufacturers and R&D
- Schedule and document calibration and maintenance activities
- Support design and engineering change processes and associated documentation
- Support internal and external audit activities and work to resolve audit nonconformities.
- Perform and support process, equipment validations.
- Investigate, disposition and close nonconformities.
- Investigate and close product complaints.
- Collect and evaluate quality data for process monitoring, management review and post market surveillance
- Perform quality activities related to CAPA processes
- Represent Quality Engineering in the development and maintenance of process and product risk assessments (e.g. pFMEAs dFMEA)
- Participate in Material Review Board reviews including material segregation, investigation, corrections and dispositions
Minimum Qualifications:
- At least 5 years engineering experience in a regulated field
- B.S. in engineering or science
- Strong knowledge of FDA QSR and ISO 13485 requirements
- Critical thinking and sound decision-making skills
- Excellent written and verbal communication skills
- Ability to independently solve problems, lead projects and influence teams
- Demonstrated ability to work as a team player with multi-disciplinary project teams
- Demonstrated ability to interpret technical information
- Experience with quality audits (lead auditor certification preferred)
- ASQ certification preferred
- Lean Six Sigma training preferred
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
- At least 5 years of engineering experience in a regulated field
- Bachelor of Science degree in engineering or science
- Strong knowledge of FDA Quality System Regulation requirements
- Strong knowledge of ISO 13485 requirements
- Critical thinking and sound decision-making skills
- Excellent written and verbal communication skills
- Ability to independently solve problems, lead projects, and influence teams
- Experience working on multidisciplinary project teams
- Ability to interpret technical information
- Experience with quality audits
- Lead auditor certification
- ASQ certification
- Lean Six Sigma training
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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.
