The Senior Quality Engineer will be responsible for planning, coordinating, and directing the quality programs and activities to ensure the quality and reliability of Nonin Medical products. Assure the timely, accurate and independent evaluation of product performance and compliance to safety, regulatory and user requirements prior to manufacturing and market release. Develop, execute and monitor quality plans and quality engineering tasks. Monitor manufacturing process validations and controls to ensure compliance with established requirements and regulatory expectations. Evaluate product field performance and reliability, monitoring customer feedback and returns. Complete failure and root cause analysis efforts, recommend corrective actions, and plan for continuous improvements.
Essential Job Functions:
Represent Quality in product development teams/projects. Develop and execute plans (quality plan, risk management plan) and requirements (reliability, safety, functionality, regulatory, usability) to ensure provisions for quality are addressed and resolved prior to product release to the market.
Participate in 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 gate reviews, and product release authorization for distribution of 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.
Responsible for reviewing, approving and taking ownership of product verification and validation plans and respective test methods.
Ensure the development of appropriate verifications, validations (software, process), and qualifications (subcontractors, system and subsystem), for both new design and changes to released product.
Maintain and serve as a technical expert on EMC standards compliance and testing.
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 direct, 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.
Manage complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis, and 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.
Lead and manage other, non-product related or continuous improvement projects, as assigned.
Required Education and Experience:
Bachelor’s Degree in Electrical Engineering
7 years related experience in Product Development, Manufacturing Engineering and/or Quality Engineering
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 perform work without appreciable direction.
Ability to represent the department in frequent cross-functional interactions and customer, subcontractor, and vendor contacts.
Ability to independently determine and develop technical solutions to a wide range of difficult problems.
Experience in product testing and compliance to EMC standards.
Knowledge of FDA QSR requirements.
Knowledge of ISO 13485 and other recognized international quality system standards
Knowledge of world class quality techniques and implementation.
Experience guiding successful completion of quality projects and ability to perform in a leadership role.
While performing the duties of this job, the employee is regularly required to sit/stand.
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
Internal Number: 2018-1231
About Nonin Medical, Inc.
For more than 30 years, Nonin Medical has designed and manufactured noninvasive patient monitoring devices for healthcare professionals and individual users. Noniin pulse oximeters, oximeters, capnographs, sensors and software dependable performance day after day, even in challenging environments. Our exclusive technologies are clinically proven to deliver consistent measurements for a broad range of patients and conditions.