Provide leadership for the development, implementation, communication and maintenance of elements of the quality system. Specialist in ISO 13485 and 21 CFR 820.30. Identify best practices, define, design, implement and train top level document structure. Ensure compliance with all regulatory requirements in an effective, timely, and responsible manner. Provide a strong detailed quality focus as well as managing all work affecting quality.
ESSENTIAL DUTIES AND RESPONSIBILITIES
FUNCTIONAL MANAGEMENT RESPONSIBILITIES
Business Strategy and Direction:
· Know and understand the department’s worldwide strategic directions.
· Define, develop and implement Quality Engineering strategies in partnership with all relevant functional groups.
· Provide regular updates to the Director on strategy execution.
· Serve as Deputy Management Representative.
· Ensure the team has a complete and accurate understanding of customer’s quality requirements, and that a deliver plan is in place.
· Participate in defining where the group can provide value on programs, both internally and externally.
· Support the process of design and development planning, proposal writing, and program budgeting.
TECHNICAL MANAGEMENT RESPONSIBILITIES
· Oversee and contribute to all departmental program process validation activities, services, and deliverables.
· Provide leadership and technical insight to grow departmental services (may include planning, protocol, and methods development, data collection, statistical analysis, and report writing).
· Responsible for effective metrology support, whether internal or external.
· Leverage Best Practices from programs and all Design sites to drive continuous improvement to the QMS.
· Support global training programs specific to each site, by development and implementation of specialized training sessions for all applicable functions. (i.e. MFAT, IQ/OQ /PQ, DFMEA, etc.)
· Conduct periodic review and maintenance of all documentation files; develop appropriate systems for worldwide document storage and access.
· Support Quality in maintaining and improving the QMS
· Provide guidance of implementing and maintaining Process Improvement and Optimization concentrating on proactive methodologies.
· Facilitate site adherence to all safety and health rules and regulations.
· Comply and follow all procedures within the company security policy.
· May perform other duties and responsibilities as assigned.
· Strong knowledge of ISO 13485, including Design Controls, and CFR 820.30, and quality requirements for combination devices and diagnostic devices.
· Solid understanding of Process Validation and Design Verification processes and practices.
· Strong proficiency in determining logistics requirements to enable company’s business goals and objectives with ability to devise and implement strategy to achieve targets.
· Proven track record of verification and validation experience, ideally in pharmaceutical or diagnostic industries.
· Demonstrated leadership and management experience.
· Strong and convincing communication skills.
· Consulting experience
EDUCATION & EXPERIENCE REQUIREMENTS
· Bachelor’s Degree in engineering required; Master’s degree preferred.
· Minimum 10 years experience, with four years in management or leadership role preferred.
· Or a combination of education, experience and/or training.
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