Quality and Regulatory Manager

The ideal candidate has:

·         a working knowledge of ISO and Regulatory Compliance

·         familiarity with the medical device industry

·         the ability to identify and correct problems within the design and development, and manufacturing of medical device process flow, including (but not limited to):

o   CAPAs

o   Calibration cycle

o   Customer service management and Complaint Handling

o   Document and Record control

o   Internal audits

o   Management Review (the non-boring version)

o   Manufacturing Quality Planning

o   Non-conforming product

o   Project Planning

o   RMAs

o   Risk Management  ISO 14791

o   Software Development IEC 62304

o   Supplier Audits

o Third-party audits

Abilities include:

·         adapting to the QMS vibe already in place

·         applying QMS to project management

·         asking  for clarification and information

·         effectively training resources in understanding procedures and proper documentation

·         troubleshooting process problems with team members and discovering solutions

·         using or learning to use: Word, Excel, PowerPoint and various other technologies

·         working independently

·         working with process owners to collaboratively write compliant, user-friendly SOPs and the necessary templates, forms, and worksheets to make them successful

Desired Skills:

·         a sense of humor

·         ability to handle multiple tasks and switch easily between them

·         creativity

·         desire to learn

·         flexibility

·         patience

·         understanding that there are many paths to the same destination

E-mail resume and cover letter to jobs@photodiagnostic.com