Mack is searching for a quality assurance manager – a proven leader who can provide focus and direction to a team of quality professionals, including the Company’s document control group – to help ensure quality, productivity and safety objectives are met.
Mack’s focus on quality is key to its success. As the manufacturing arm for our customers, Mack has built a worldwide reputation for injection molding, machining, design work, sheet metal fabrication and contract manufacturing. The Mack team helps launch new products for some of the top fortune 500 companies, as well as cutting-edge technologies for start-up organizations. That is in part because of our mission of Total Customer Satisfaction, and the large role the quality team plays in helping the organization achieve it.
In addition to providing leadership of department personnel, the quality assurance manager serves as the primary contact for external audit coordination and hosting, as well as oversees the northern division’s internal auditing program. This includes regulatory audits by the U.S. Food & Drug Administration (FDA), notified bodies and other agencies, customers. As this role requires communicating with outside agencies, including regulatory reporting, the quality assurance manager must be a strong communicator with an attention to detail. Further responsibilities include maintaining the control and security of archived controlled documents; maintaining FDA establishment registration and device listings; ensuring procedures and work instructions are compliant with applicable domestic and international medical device regulatory and quality standards; and maintaining current updates to CGMP and ISO guidelines and conducting training to the standards as appropriate. The quality assurance manager monitors problem reports – e.g. CCRs, NMRs and NCRs – ageing, driving timely closures, as well as develops, designs and maintains quality system metrics.
The ideal candidate will have a bachelor’s degree, preferably in an engineering or STEM discipline, as well as three to five years of experience in an ISO or 21 CFR Part 820 Quality System environment. Minimum education requirements include an Associate’s degree, plus three to five years’ experience in an ISO or 21 CFR Part 820 Quality System environment. Candidates are also should be a certified ISO Lead Auditor or ASQ Quality Auditor. To perform this job successfully, an individual should have knowledge of word processing, spreadsheet, product life cycle management (PLM) and enterprise resource planning software, while candidates given preference for specific experience with Agile and Mapics.
Employees are one of the Company’s most valuable assets, and Mack is committed to honoring their contributions through competitive compensation packages, diverse career paths, advancement opportunities and by nurturing a team-oriented, engaging work environment. This position is located in beautiful southern Vermont with an unparalleled quality of life.
If interested, please complete Mack’s on-line application form (see link below) and send it with your resume, compensation expectations and a letter of introduction to:
Mack Molding Company
608 Warm Brook Road
Arlington, VT 05250
Attn: Human Resources
Resumes accepted from qualified applicants only.