Description
A growing and highly regarded custom medical and automotive injection molding company is searching for a Vice President of Quality and Regulatory Affairs. The Vice President of Quality and Regulatory Affairs (VPQRA) is responsible for establishing the strategic direction for continuous quality improvement and the implementation of corporate quality policies globally across all facilities. The VPQRA will benchmark best practices for the sustained improvement of critical quality and business processes throughout the corporation. The VPQRA works with senior management to identify areas of improvement, creates projects, gathers resources to work on projects, and manages the progress of projects to support the company’s short and long-range business objectives. This individual will oversee the deployment of quality analysis tools and will act as a resource for front line Quality Managers, Executive Management and other members of the Management Team.
SPECIFIC RESPONSIBILITIES:
Lead company-wide initiatives related to developing, implementing, streamlining, and strengthening quality and environmental systems, which comply with ISO 9001, ISO/TS 16949, ISO 13485, ISO 14001, GHTF Guidelines, FDA QSR and ISO 28000.
Lead company SPC efforts while promoting standardization among plant practices, documentation, and systems related to Quality, Manufacturing and Engineering.
Support New Program Launch Design Review Meetings and engage with project teams on IQ/OQ/PQ activities including FMEA and Control Plan review to ensure consistency.
Review and/or negotiate customer-specific requirements and manuals to ensure that corporate quality systems comply with such customer expectations.
Manage the company’s corporate internal audit function and actively support layered audit programs by personally conducting quality system and process-level audits at various company locations.
Function as the main interface with regulatory and registration bodies; negotiate contracts and ensure internal compliance.
Provide regulatory, GMP and medical device/pharmaceutical expertise to advance the corporation’s medical device assembly and contract manufacturing business.
Manage/Delegate supplier quality activities including supplier selection, supplier corrective actions, supplier audits, and administration of the Supplier Excellence Manual.
In addition to an annual salary in the $100,000 to $125,000 range, the company offers very competitive medical benefits, a 401k with matching, a very good relocation package, etc.
Requirements
Four year Engineering, Science or Math degree is required and an MBA/MA is preferred.
Minimum of 12 years of quality management experience (at the director level or above) with specific experience in the custom injection molding of medical devices/components and automotive parts (PPAP and related automotive industry practices).
ASQ Certified Quality Engineer, Quality Auditor, Quality Manager, Six Sigma Black Belt or similar achievements preferred.
Computer literate in programs such as Word, Excel, PowerPoint, etc.
Strong SPC knowledge and application experience.
Well versed in TS 16949, ISO 9001, 13485, and FDA’s Title 21 CFR’s.
Familiarity with medical/FDA guidelines as applies to manufacturing processes and related documentation, and/or direct experience with medical device manufacturing. FDA Regulatory exposure and/or RAC certification a plus.
Practitioner level – Lean Manufacturing experience with a record of accomplishment in leading Kaizen events, VSM and overall process improvement activities.
Knowledge and experience in control plan development, product print and specification understanding, customer interface experience.
Knowledge of molding process and procedures.
Excellent written and verbal communications skills.
Ability to travel as needed
For additional information about this position, please contact Jim Heilman at Discovery Personnel: (952) 431-2500.
