This position influences the Quality Management System for all Welch Fluorocarbon team members and processes. The Quality Manager will interface with all teams in the development and execution of plans to improve company-wide quality. The Quality Manager serves as the catalyst for change and continuous improvement within the organization. He/she will lead and oversee a three person quality team.
- Establish, maintain and monitor the Quality Management System and quality metrics.
- Maintain and improve compliance with ISO 13485:20126 and additional customer-related quality requirements.
- Conduct periodic Leadership Reviews of the QMS and update company leadership on results.
- Lead the internal audit process and recommend changes for compliance with Welch standards, ISO standards and customer quality requirements.
- Evaluate all customer expressions of dissatisfaction – complaints and RMA’s – and implement appropriate corrective and preventive actions.
- Facilitate and lead all customer on-site audits and expeditiously complete customer self-surveys.
- This position is the company Leadership Representative for the QMS.
Education and Experience:
- Minimum 4 year degree in a technical discipline (BSME or BSEE preferred)
- Minimum 4 to 8 years Quality Management experience in an ISO manufacturing environment (Medical Device industry experience preferred).
- Excellent verbal and written communication and organization skills
- Experience working in a team environment
Job Knowledge, Skills and Abilities
- Ability to lead teams and influence decisions based on facts and process thinking
- Ability to build credibility and trust by demonstrating high ethical standards
- Excellent organizational, interpersonal and time management skills
- Excellent verbal and written communication skills that are action oriented and customer focused.
- Demonstrated proficiency with MS Word Office Suite
- Experience with understanding and using MRP/ERP software systems.
- Working knowledge of data management systems and statistical tools.
- Direct supervision and leadership of Quality Assurance personnel
- Light physical effort for the occasionally movement of product or documentation
- Regularly required to sit, stand or walk throughout the facility.
- This position requires periods of working at a desk and performing tasks on a computer.
- Significant periods of standing or walking throughout the facility to interface with other team members.
Personal Protective Equipment:
- The use of Safety Glasses is required in all production areas of the facility
If you are interested in applying for the position listed above please email your resume, cover letter and contact information for consideration to: [email protected]