The Sr. Quality System Specialist will successfully develop, implement, maintain, evaluate and measure effectivity of the Nonin Quality System and internal and external compliance with its requirements to meet global regulations.
Essential Job Functions:
- Audit and evaluate the compliance of the Nonin Quality System to applicable standards such as FDA Quality System Regulation, ISO 13485, Canadian Medical Device Regulation and the Medical Device Directive.
- Actively participate in, lead and facilitate continuous improvement of the Quality System with a focus on customer satisfaction, internal performance metrics and internal audits that focus beyond compliance.
- Maintain certification by facilitating 3rd party audits including FDA, ISO, MDSAP, etc.
- Conduct process-based internal audits that measure Nonin's Quality System compliance to regulations and established policies and procedures.
- Update QMS procedures as applicable.
- Lead, train and manage internal audit team.
- Drive the implementation of new Quality System standard/regulation requirements (MDR, ISO, etc).
- Key contact for product certification agencies (UL, CSA, NRTL)
- Liaison with factory representative
- Facilitate unannounced factory inspections
- Project quoting and scheduling
- Manage project hurdles and support QA Engineers to meet deadlines.
- Prepare and deliver comprehensive Quality System training throughout organization.
- Develop, evaluate and maintain metrics to assess the performance of the Quality System.
- Manage the Nonin CAPA system. Ensure corrective and preventive actions are implemented, monitored and evaluated for effectiveness.
- Investigate field product issues and complaints to identify root cause and implement corrective action.
- Facilitate 2nd party audits (customer).
- Respond to outside customer requests and surveys.
- Participate by providing input and post market information on Risk Assessment activities including, but not limited to: audits, CAPAs, & complaints.
Required Education and Experience:
- Bachelor’s Degree.
- 5+ years related work experience.
Required Knowledge, Skills & Abilities:
- Experience with FDA regulations, ISO 13485, MDD, Canada Medical Device Regulations
- Experience with 3rd Party Audits and customer audits
- Experience with product audits (UL, CSA, etc.)
- Strong technical ability.
- Strong interpersonal, communication (both written and oral) and analytical skills.
- Ability to work independently and as a team member
- Electrical Engineering Bachelor’s Degree
- ASQ Certified Quality Auditor.
- Understanding of 60601-1 series of standards
- Sit/stand for 8 hours/day.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.