Lead Quality Engineer

• BASIC PURPOSE

Responsible for development and implementation of Quality Assurance programs, and other critical quality systems to ensure compliance with all governmental regulations and corporate policies.

• DIMENSIONS

 Oversees budget of QA Department.

 Must have management skills necessary to direct departmental operations, set priorities, establish goals, develop and implement action plans, develop and maintain departmental budget, and manage human resources.

 Directly supervises QA team leaders.

 Independently solves complex problems related to QA, human resource issues, and cross-departmental quality improvement initiatives

 Able to shift priorities in rapid timeframe. Requires constant attention to details and meeting deadlines.

• KNOWLEDGE/EXPERIENCE

Essential:

 Quality professional with 5+ years of hands on experience with increasing responsibility in a QA function.

 Quality improvement tools and techniques (PDCA, Lean Thinking, Six Sigma, etc.).

 Strong hands on leadership and management skills.

 Well-organized and detailed oriented professional, with strong verbal and written communication skills.

 Must be able to develop and maintain relationships/partnerships and to work collaboratively both internally and externally.

Desired:

 Previous management responsibility for Regulatory Affairs preferred, but not required.

 Deliver on corporate objectives, on schedule, working cross-functionally in a fast paced and dynamic environment.

• PRINCIPAL ACCOUNTABILITIES

 Provide direction and leadership in the development and implementation of critical quality systems in support of the manufacturing facilities.

 Coordinate with the corporate supplier evaluation program to assure the needs of operations are satisfied in accordance with established compliance guidelines.

 Provide regulatory guidance to site management for the development of new products, test methodology, and new manufacturing processes.

 Participate in preparing correspondence and corrective action plans in response to regulatory inspections and audits.

 Assure optimum performance of group function. Recommend and implement techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices.

 Oversee the development and maintenance of staff to manage controlled document and records, internal audits, Corrective and Preventative Actions (CAPAs) and training processes and systems.