Nonin Medical, Inc. is a rapidly growing international medical device manufacturer that has been designing and distributing high quality medical monitoring devices since 1986. Headquartered in Plymouth, MN, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere. We are currently searching for a dynamic Quality Engineer to join our Quality Assurance Team.
Plan and coordinate quality programs and activities to ensure the quality and reliability of Nonin Medical products. Assure the timely, accurate evaluation of product performance and compliance to safety and regulatory requirements prior to manufacturing and market release. Develop, execute and/or monitor quality plans and quality engineering tasks, as well as, manufacturing process validations and controls to ensure compliance with established requirements and regulatory expectations. Provide support for released products, evaluate product field performance and reliability recommend corrective actions, and plan for continuous improvements, as assigned.
Essential Duties and Responsibilities:
- Represent Quality in product development teams/projects. Work with Sr. Quality Engineers or QA Manager to develop & execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory, usability) to ensure provisions for quality are addressed and resolved prior to release.
- Coordinate with the development of essential design control deliverables including, but not limited to product performance analysis on similar products, essential requirements checklist, design verification, design validation, design reviews, phase reviews, and product release authorization for distribution of product.
- Work closely with Product Development, the project team, and Sr. Quality Engineers or QA Manager to develop appropriate verifications, validations (software, process), and qualifications (subcontractors, system and subsystem), for both new design and changes to released product.
- Review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.
- Review, approve and develop (as needed) product verification plans and respective test methods.
- Support validation efforts of approved testing to assure compliance.
- Participate in CR/CO process to review and approve engineering change requests.
- Participate in Material Review Board (MRB) to review and disposition nonconformities and to work with Supplier Quality Engineering to coordinate supplier corrective actions.
- Work with Manufacturing to coordinate, and monitor production processes to ensure compliance to FDA QSR, ISO 13485, and other applicable regulatory requirements (JPAL, Canada, etc.) and to ensure that safe and effective products are produced.
- Provide validation support by applying manufacturing quality tools including, but not limited to: FMEA, DFMEA, PFMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.
- Lead and/or Participate in complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis, & document health risk assessment.
- Compile and institute quality metrics to present at QIT meetings to trend, recommend, and implement corrective actions and appropriate follow-up, when necessary.
- Required Education & Experience:
- Bachelors Degree in Engineering, Biotechnology, Computer Science, Engineering Technology or equivalent technical Degree; or equivalent combination of education and experience.
- Required Knowledge, Skills & Abilities:
- Ability to read, analyze, and interpret technical procedures and governmental regulations.
- Ability to write technical reports, business correspondence, technical procedures, as well as, administrative procedures.
- Ability to present proposals, data, and issues to Nonin Medical personnel at all levels.
- Ability to independently determine and develop an approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
- Ability to represent the department in frequent cross-functional interactions and possible customer, subcontractor, or vendor contacts.
- Ability to provide solutions to difficult technical issues associated with specific projects.
- Ability to determine and develop technical solutions to a wide range of difficult problems.
- Knowledge of FDA QSR requirements.
- Knowledge of ISO 13485 and other recognized international quality system standards.
- Knowledge of world class quality techniques and implementation.
- Guide the successful completion of major programs and have an ability to perform in a leadership role.
- While performing the duties of this job, the employee is regularly required to sit, stand, walk.
- Must be able to examine assemblies and subassemblies using a microscope.
- Employee must occasionally lift and/or move up to 50 pounds.
- On call or after hours support – may be required to support process and design validation efforts during weekends or after work hours
Qualified candidates can mail, e-mail, or fax resume and salary requirements to:
Nonin Medical, Inc.
Attention: HR Department
13700 1st Avenue North
Plymouth, Minnesota 55441-5443