Responsibilities:

• Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned personnel, and when required assist other Quality areas in the successful performance of these activities.
• Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner.
• Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following - PMT, QWT, Kaizan, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
• Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and quality requirements. Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
• Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility.
• Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #5 for less experienced individuals within the plant.
• Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
• Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis.
• Assists and writes validations for equipment, product changes and computer systems.
• Assists with vendor audits/assessments and provides ongoing feedback related to quality issues.

Qualifications:

• Understand scientific strategies and be able to invent new methods or new avenues of investigation.
• Good interpersonal/communication/influencing/negation skills
• Good project management skills
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices (GLP), and Application of Good Manufacturing Practices (GMP).

Required Experience:

• 2-3 years' experience in auditing techniques, interpreting regulations and quality systems.
• Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.