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PURPOSE:

Responsible for developing, implementing, and managing internal and external quality control systems and procedures which ensure continuous production of highly-engineered elastomeric components for the healthcare industry, including raw materials, goods in process and finished goods, consistent with established regulatory requirements, quality certifications (ISO-9001 and ISO-13485), customer specifications, and production goals. Lead, oversee, and direct the entire quality department. Coordinate customer and supplier relations.

ESSENTIAL FUNCTIONS:

Develop the Company Overall Quality Strategy to achieve the company goals and meet and exceed our customer expectations.

Develop, Design and maintain the Quality Management System and ensure its implementation and observance in the manufacturing process

Ensure outstanding quality department staffing. Maintain discipline, morale, and harmonious personnel relations within quality department staff in accordance with company policy. Hire, supervise, and evaluate the work of quality department staff. Make recommendations for performance improvement, wage adjustments, promotions, transfers and terminations within the quality department.

Plan, layout and assign work according to schedule and individual skills/abilities for the most efficient and effective quality operation. Follow setup and progression of work, anticipating and investigating delays or inadequate performance. Ensure that equipment, materials and supplies are available for work assignments. Take corrective action where necessary.

Act as management representative for quality and environmental systems, assume the authority and responsibility for compliance and performance of the quality and environmental systems.

Develop and maintain quality standards FOR manufacturing, inspection and shipping personnel; utilize Robin's ERP system (IQMS) to maintain, process and analyze data; maintain internal and external compliance with record keeping requirements.

Work with suppliers and customers to verify specifications, critical dimensions, formulations, and internal sample inspection deadlines; resolve problems, returns and the like; initiate corrective action as required.

Investigate discrepancies and develop requisite corrective actions, working with engineering, technical and manufacturing personnel.

Certify, design, document and implement methods for process control, process improvement, testing (failure analysis), and inspection.

Develop, execute and analyze the effectiveness of quality-reporting measures.

Report to management on quality issues, trends, and losses.

Review customer specifications, change requests and contracts to ensure that necessary criteria and provisions are included in the quality and process plans.

Enforce compliance with Healthcare's materials supply requirements.

Conduct internal quality audits within the department.

Interface with supplier and customer quality representative's concerning problems with quality assurance and ensure that effective and timely corrective and preventive actions are implemented.

Ensure the highest level of internal and external customer service.

Coordinate quality objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs.

Maintain an active and contributing role to internal and inter-divisional continuous improvement, ISO-9001 and ISO-13485 teams, including audit preparations.

Serve as point person in customer and agency audits.

ADDITIONAL SKILLS OR CREDENTIALS:

Associate or Bachelor's degree in Engineering or Technology. Equivalent combination of education and experience will be considered in lieu of a degree.

Requires a minimum of 3 years of experience in quality control functions, including but not limited to ISO 13485, ISO 9001, APQP, PPAP, AIAG core tools (FMEA, Control Plan, etc.).

Knowledgeable in ISO and IATF Certification, ISO 13485, ISO 9001 and ISO 14001 standards.

Knowledge of FDA 21 CFR 820 would be a plus.

Excellent verbal and written communication skills

Demonstrated hands-on approach to daily challenges.

Experience in writing procedures, instructions and 8D-5 why reports.

Experience or knowledge of layered audits.

Experience training other employees preferred.

Strong leadership skills required.

Physical Demands:

While performing the duties of this job, the employee is regularly required to walk, use hands to position or move, reach with hands and arms, talk, and hear.

The employee frequently is required to stand, sit, climb, balance, stoop, kneel, crouch, or crawl.

The employee must regularly lift and/or move up to 10 lbs., frequently lift and/ or move up to 25 lbs. and occasionally lift and/or move up to 40 bs.

Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.