Quality Manager
4 weeks ago
SUMMARY
Seeking a Quality Manager in the Greater Boston area Our client is a custom medical materials and manufacturing company experiencing growth. Relocation assistance provided.
RESPONSIBLITIES
- Responsible for collaborating with internal business partners to solidify quality systems and quality metrics, while identifying specific areas of opportunity to provide world class service to customers.
- Identify gaps in quality processes, training opportunities, and performance issues in support of the business goals.
- Work in conjunction with suppliers and customers to ensure expedient response and flow of information to resolve issues.
- Identify opportunities to develop, implement and monitor policies and procedures to ensure compliance with customer, internal and supplier quality goals.
- Audit quality procedures to evaluate materials, products, processes, and systems in relation to company and customer specifications; support and direct the inspection and test of raw materials, in-process and finished materials.
- Lead and Support ISO9001 Yearly Audits
- Ensure nonconforming materials are dealt with in a timely and cost-effective manner, in accordance with company procedures and policies.
- Lead continuous improvement initiatives to reduce nonconformance rate and costs.
- Examine returned material from customers, determine disposition and resolve claims.
- Address customer requests for regulatory compliance information.
- Lead problem solving activities for internal/external concerns.
REQUIREMENTS
- Bachelor's degree in business or engineering, and/or equivalent work experience.
- A minimum of 3 years of experience in Quality Management within a manufacturing operation.
- Knowledge of fabric medical device manufacturing or textile materials is a big plus.
- Thorough understanding of ISO 9001 and knowledge of ISO 13485
- Certified Auditor or willingness to become a Certified Auditor
- Proficient with computers, including Microsoft Office Suite and ability to understand MRP systems.
- Ability to apply well developed time management skills to define priorities and implement activities tailored to meet requirements and deadlines.
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