Quality Assurance Manager

Job Summary

This role is responsible for all aspects of the site Quality function and compliance to third-party certifications such as ISO 13485 and FDA part 820 regulations. This leader will develop, implement and maintain the site’s quality management systems and policies to ensure compliance with all industry standards, regulations, and global company 1 QMS processes. The manager will act with direct responsibility over site quality personnel.

Responsibilities

• Shall manage all personnel as assigned.
• Monitor and advise senior management on the performance of the QMS.
• Generate documentation of keys metrics at defined intervals.
• Oversee maintenance of document control and related databases.
• Review, assign, and ensure effective execution of corrective actions. Shall validate effectiveness of corrective actions.
• Encourage and sustain continuous quality improvement efforts.
• Responsible for schedule, performance, and closure of all internal, supplier and customer audits.
• Direct required activities to maintain regulatory compliance.
• Implement & maintain quality management system compliant with ISO 13485 and US FDA cfr Vol21 Part 820 requirements.
• Create, implement, and validate quality procedures, work instructions, and other documentation under corporate control.
• Compile and hold Management Reviews and oversee completion of action items identified.

Qualifications

• Dedication to accuracy, including measurement and documentation requirements.
• Excellent oral and written communication skills; must be able to effectively interact with internal and external customers.
• Self-starter with initiative who requires minimal supervision.
• Works with integrity and ethical business practices.
• Thorough in completing tasks and focused on quality output.
• Team player with a positive, encouraging demeanor.
• Ability to enforce company policy and values.
• Proficient in process controls (validations, acceptance activity, pFMEA, control plans)
• Exceptional organizational and multi-tasking skills. Can professionally manage and motivate internal cross-functional teams.
• Knowledge of document control practices including maintenance of archival databases.
• Conducting and fielding Quality Audits.
• Extensive knowledge of Statistical Methods for manufacturing.
• Proficient in metrology and calibration standards.
• Plastics injection molding knowledge a plus.

Education and/or Experience

• Bachelor’s degree in Engineering or related field; 5-10 Years in Quality Engineering in manufacturing environment.
• Certified QM or QE.
• Experience with QMS, Process Controls, Operations Quality
• Experience working in the medical device industry
• Experience using Minitab.
• Proficient in metrology and calibration standards.