The desired candidate will have prior direct management experience in a QA role working for a medical device company. Specific experience and responsibilities will include, but not limited to, ISO 13485:2003, FDA compliance, Quality System Regulations, while spearheading and directing the QA function within the company. The QA Manager will be responsible for: quality assurance, incoming inspection, quality assurance, quality compliance and quality engineering. In addition, he or she will also communicate with suppliers, the manufacturing facilities and customers on quality as well as serve as principle contact for Quality Audits, surveys, and corrective actions.
ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES:
Direct and manage the QA function within the company
Develop, administer and maintain quality assurance procedures, including inspection procedures and document control
Responsible for document control function
Identify, analyze and report quality assurance metrics while embracing a Kaizen approach to work
Perform investigations associated with any Non-Conforming Materials (NCMR) using Root Cause Analysis through complete follow thru with documentation (CAPA and SCARs)
Track and report Customer Complaints and implement improvement
Manage and lead the Internal Audit and Supplier Audit Programs to ensure compliance to regulations
Assist in preparation for both external and internal audits
Review for completeness and adequacy of Design History record
Responsible for compliance with company’s quality system requirements through training and adherence to policies, procedures and processes
Bachelor’s degree, preferably in a technical discipline
7+ yrs experience in the medical device industry
5+ yrs supervisory experience in a QA role
Thorough knowledge of FDA Quality System requirements, ISO and GMP
ASQ Certification, or equivalent
Excellent verbal, written communication and problem solving skills
Possess above-average interpersonal skills
Ability to multi-task with excellent attention to detail
Knowledge of MS Office Suite, and of Statistical Process Control Practices
Additional Salary Information: Highly competitive salary based upon experience
Spectra Medical Devices, Inc. was founded in 1995 and is a market leader in manufacturing custom procedural needles.
Spectra Medical Devices has become one of the largest procedural needle manufacturers in the world, with substantial market share in over 20 countries. Spectra utilizes the latest state-of-the-art manufacturing, measuring and inspection systems, along with over 200 years of senio...r staff needle manufacturing experience.
Spectra has been awarded several US patents for special needle processing and product. Our primary focus is on patient safety, achieving substantial growth through quality and innovation. Spectra has four manufacturing plants worldwide employing over 200 personnel. Our corporate headquarters is located in Wilmington, Massachusetts.
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