Government, Regulatory and Code, Healthcare, Quality, Quality Engineering
Flex-Cell Precision, Inc., a high-end, Pennsylvania Machine Shop, seeks an experienced, motivated and energetic Quality Assurance Manager. The position is responsible for the overall quality program, and maintenance and application of our existing ISO 9001:2015 & ISO 13485:2016 quality management systems (QMS). The position oversees the Quality Lab as well as leading and supervising a small group of Quality Engineers & Technicians.
Maintain QMS compliance to current standards ( ISO 9001:2015/ISO 13485:2016 ).
Foster continuous improvement Company wide.
Champion positive trends in KPI’s by promoting a quality-centric culture.
Introduce and maintain quality principals and tools ( SPC/Lean/Six Sigma etc. ) to complement existing processes.
Basic responsibilities include:
• Administering and enhancing the Quality Management System (QMS)
• QMS Representative (Management Rep.)
• Staying abreast of ISO, industry, regulatory and customer standards/requirements and ascertain any impact any changes may have on the Quality Management System. Making the necessary adjustments to maintain compliance including upgrading to the most current ISO standard.
• Lead Internal Auditor responsibilities.
• Prepares and Leads Customer, Vendor, Internal and External (Registrar) Audits.
• Corrective/Preventative Action and Non-Conformance responsibility.
• Training site personnel to ensure an understanding and adherence to QMS.
• Prepare and conduct Material Review Board (MRB) meetings as required.
• Participate in internal meetings as required.
• Develop new quality policies and Standard Operating Procedures as needed
• Support continuous improvement initiatives in conjunction with Management by coordinating the collection and analysis of quality metrics and audit results.
• Manage calibration of measurement and test equipment.
• Visits Customers and Vendors regarding quality related issues/audits as required.
• Review Customer specifications as needed.
• Administer process validation activity.
• Continually assess risk as it pertains to ISO standards (QMS)
• Conducts annual performance reviews of Quality Team members.
• Bachelor’s Degree in engineering or related technical field.
• Significant experience in ISO 9001:2015 & ISO 13485:2016.
• Significant experience in risk assessment and management.
• Strong leadership skills.
• CQA, CQE and/or CMQ certification preferred.
• Data analysis skills.
• Strong written and verbal communications skills.
• Organized, goal oriented and results driven.
• Ability to contribute effectively in a team environment.
• 5+ years of Quality Management experience in a manufacturing/job shop environment.
• Knowledge of quality tools and principles.
• Experienced in project management.
• Problem solving skills.
• Microsoft Office Suite proficiency.
• Must be flexible and able to handle multiple tasks.
Additional Salary Information: Generous Benefits Package including 401k
About Flex-Cell Precision, Inc.
Flex-Cell Precision, Inc. is a world class machining firm servicing the Medical, Pharma, and Electronic Communications industries. Established in 1991, and currently operating in beautiful Lancaster County PA, we continue to grow with a team of dedicated, highly skilled associates and deliver high quality products to our customers with acute attention to their needs.