Lead Quality Engineer

1. 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. 

2. 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. 

3. 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. 

4. 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. 

• Travel will be needed for this position, approximately 10%. 

• Initial interviews will be completed via phone and Skype due to the location of the primary manager. 

• This position has a possibility of turning perm, should the candidate be successful and there be an open head count. 

• Need someone ASAP!!!!

All your information will be kept confidential according to EEO guidelines.