We believe that great healthcare is an essential safeguard of human dignity.

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.

If you share our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion, and are looking to contribute and grow in a fast-paced environment, join us to enhance our customer experience with dignity, at the heart of everything.

Laborie Medical Technologies is currently searching for a Senior Quality Engineer to join our team in the Portsmouth, NH office.

Position Overview:

The Senior Quality Engineer is responsible for ensuring that the technical, regulatory, and quality requirements are met both within the Quality Management System and throughout the product life cycle.

How you contribute:

• Develop, plan, and perform product, process monitoring & measurement activities.
• Develop verification/validation protocols and reports and perform the necessary experimentation as needed.
• Investigate proposed process/product changes to assure continued safety and quality.
• Maintain a thorough knowledge of current QSR and ISO requirements as they apply to the medical device industry.
• Develop and institute statistical techniques and trending to identify potential corrective or preventive actions.
• Initiate, plan, and perform corrective and preventative actions. Ensure timely resolution of corrective actions and preventive actions.
• Perform other related duties or special assignments as requested and specified.
• Provide leadership and Subject Matter Expertise (SME) to Quality Engineering function and mentor less experienced Quality personnel.
• Develop strategies for validation of manufacturing processes, test methods, and quality processes.
• Collaborate with design team personnel in the development of new products, utilizing engineering skills.
• Represent quality in the review and approval of proposed change orders, deviations and nonconforming material records to determine the effect of the proposed changes on materials, products and processes.
• Recommend and implement process and product changes/improvements.
• Lead and support design/development activities for new or modifies products and processes, including design transfer.
• Assist in the design/development activities for new or modified products and processes, including design transfer.
• Validate manufacturing processes, test methods, and quality processes as requested.
• Manage regulatory and quality projects with external agencies and test labs to ensure that the appropriate certification and testing is performed.
• Perform and document risk analysis and make decisions based on risk management principles.

Qualifications:

• Minimal 9 years’ experience working in technical medical device quality and compliance roles with HS diploma and applicable certifications.
• Minimal 6 years’ experience working in technical medical device quality and compliance roles with BS degree in an engineering or related scientific field.
• Minimal 3 years' experience working in technical medical device quality and compliance roles with MS degree in an engineering, related scientific field, or MBA.
• Must possess the ability to write clear, concise and effective reports and procedures, learn quickly with guidance and training and work with minimal direct supervision.
• Computer literacy with experience in spreadsheet, database and word-processing applications.
• Processing and product evaluation experience.
• Knowledgeable of Quality System Regulation (CFR 820) and ISO requirements.
• Must be capable of establishing and maintaining an effective working relationship with manufacturing and technical personnel at all levels.
• Knowledge of statistical methods and the applications thereof

How we take care of you:

• Paid time off and Volunteer time
• Paid holidays
• Flexible work schedule and environment
• Medical, Dental, Vision, and Employee Wellbeing programs
• Health Savings Account and Flexible Spending Account
• Parental Leave and Adoption Services
• 401k Retirement Plan with Company Match
• Company-paid short-term and long-term disability and Basic Life and AD&D

Laborie is a specialty manufacturer and supplier of medical technologies and devices, committed to excellence in diagnostics and therapeutics for Urological, Gastrointestinal, Obstetric, Gynecological, and Neonatal healthcare and committed to equal employment opportunity 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.