Senior, Manufacturing Quality Engineer

• 7 years of experience or equivalent experience in Medical Device manufacturing and the application of ISOCFR820 ISO13485 IEC62304 IEC60601.
• Bachelors degree in engineering or life science discipline
• Experience with manufacturing transfer process validation and sustaining of mechanical and software driven devices.
• Experience with process risk management creation and maintenance.
• Experience with test method development and the validation of those test methods.
• Experience with the development and implementation of inspection plans.
• Strong technical ability using computational tools and electronic QMS.
• Ability to quickly learn new applications tools and concepts.
• Strong work ethic and an ability to excel in a flexible and fast-paced work environment.
• Ability to provide guidance and mentorship of good quality principles and practices.

• Masters degree in engineering or life science discipline
• Preferred Experience
• Excellent written/oral communication skills required.
• Must be able to work effectively with diverse groups of people
• Six Sigma (DMAIC)
• Lean
  

• Requires normal visual acuity and hearing.
• Typically employees sit comfortably to do their work interspersed by brief periods of standing walking bending carrying papers and books and extensive periods requiring the use of computer terminals to accomplish work objectives.
• Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.
• Additional skills may be required to perform additional task(s) specific to work location department or line of business.

• Predominantly operates in an office and manufacturing environment
• Onsite (not hybrid or remote)

• Metrology process mapping pFMEA control planning test method validation validation process improvements CAPA NC and change management.
• Ability to review and approve changes to currently commercialized product w.r.t. the process risk management of the product.
• Applies statistics to make business decisions.
• Ability to conduct failure investigation and root cause analysis.
• Must be able to work in lower maturity processes using critical thought to provide pathways for business continuity and improve the systems.
• Coordinate and work closely with other engineering logistics financial and program management disciplines to define system specifications and requirements.
• Attends and participates in departmental meetings.
• Attends seminars and training sessions necessary to maintain.
• appropriate level of professional competence.
• Ensures all department compliance guidelines are met.
• Attends all meetings in-services training or continuing education as delegated by the supervisor.
• Provides customer focused interactions.
• Performs all duties necessary for the department as per department policies and procedures.
• Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.

Required Experience:

IC