QUALITY ASSURANCE MANAGER OrthoAccel Technologies, Inc.
This position is responsible for leading, managing and controlling all aspects of the company Quality Management System (QMS), will report to OrthoAccel?s Chief Operations Officer and will be expected to apply experience, creativity, planning, leadership, intellectual horsepower and technical competence to develop and maintain operational excellence in the functions of Product Quality and Regulatory Compliance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Ensure that processes needed for the (QMS) are established, implemented and maintained.
Accountable for being the management representative with responsibility and authority for the QMS and regulatory requirements.
Establish and maintain a fully compliant complaint handling process including all provisions for Adverse Event reporting (i.e.; 21 CFR 803, Medical Device Reports) for all products commercialized by OrthoAccel Technologies, Inc.
Responsible for the preparation and presentation of QMS data to Executive Management on a periodic basis.
Verify documentation and design controls are appropriate for organization, including design history files (DHF), device master records (DMR), device history records (DHR), standard operating procedures (SOP), and change records.
Serve as key contact on FDA inquiries.
Lead company?s efforts in regulatory agency audits including FDA and Notified Body and respond to non-conformities, as necessary
Perform and lead internal auditing to maintain QMS compliance
Conduct supplier evaluations and on site audits
Provide regulatory guidance in matters of product and labeling change control
Issue ?Corrective Action? documentation to suppliers and subsequent follow-up.
Address customer complaints and provide corrective action.
Interface/ communicate with all functional groups to ensure awareness of regulatory and quality requirements
Lead company internal efforts in development and administration of a Six Sigma environment.
Collect, perform trend analysis, and drive corrective action on process and hardware quality data using advanced tools and methodologies.
Lead quality participation in new product development phase gate process, including making improvements to the process
Track, analyze and publish assigned monthly Quality metrics
Assist customer service in responding to technical questions, looking for emerging quality trends
Monitor & manage as necessary EMS supplier quality program
Drive & lead quality aspects of Key Supplier QBR?s
Using Six Sigma methodologies, drive improvements in product quality while also driving down product cost
MINIMUM REQUIREMENTS AND QUALIFICATION
BS degree in engineering discipline (Quality, ME, Industrial, Manufacturing, EE) or equivalent experience
Minimum ten (10) years in hardware product quality and design environment
Experience in managing the following standards/ requirements
ISO 13485 Medical Devices ? Quality Management System
US FDA CFR21Part820 (QSR)
ISO 14971 Medical Devices ? Application of Risk Management to Medical Devices
Medical Device Directive (93/42/EEC ? MDD)
SOR/98-282 Canadian Medical Device Regulations
ISO 13485:2003 Lead Auditor Certification and/or ASQ Quality Auditor a plus
ASQ Certified Auditor, Engineer and/or Inspector
Certified Six Sigma Black Belt
Experience with electronic medical devices
Commitment to highest standards of excellence and integrity
MUST have a positive, ?can do? attitude and show desire and capability to solve problems
MUST demonstrate a Drive for Results, not just a reporter of results
Excellent oral and written communications skills
Advanced skills in Excel, Word & PowerPoint
Well organized in documentation and thought
Must be able to work both independently and in a matrix environment
Must be proficient in Player/Coach roles.
Must have startup experience
DESIRED SKILLS AND QUALIFICATIONS
Advanced degree a plus
Lean Certification a plus
Position will require approximately 10% travel
Able to travel internal and external of US
||Houston, TX |