Quality Manager - Medical Device - HireFocus Recruiting, LLC

Are you ready to elevate quality standards in the dynamic world of medical devices?

Seeking a seasoned Quality Manager with a proven track record in ensuring excellence and compliance. If you're passionate about quality and possess extensive experience in the medical device industry, we want to hear from you!

Responsibilities:

• Provide direction to Manufacturing and Inspection personnel, ensuring the integrity of our quality systems.
• Implement policies for compliance with customer, internal, and supplier quality goals.
• Be the quality expert in technical discussions, representing our interests in negotiations and claim resolutions.
• Conduct audits to evaluate materials, products, processes, and systems for compliance with specifications.
• Medical fabric for medical devices; knee, ankle, arm braces along with surgical gowns knowledge.
• Lead ISO9001 Yearly Audits and continuous improvement initiatives to minimize nonconformance.
• Swiftly handle nonconforming materials, ensuring adherence to company procedures.
• Champion problem-solving activities for both internal and external concerns.
• Oversee and manage the on-site laboratory, including employee appraisals.

Qualifications:

• Bachelor's degree in business or engineering, and/or equivalent work experience.
• Minimum 5+ years of Quality Management experience in manufacturing with 3 of the years in leadership.
• 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.
• Exceptional time management skills to meet requirements and deadlines.

Location: Boston MA 

Salary: commensurate with experience. Includes bonus and will relocate the right individual. Excellent benefits and growth potential!!

HireFocus Recruiting is a full-service recruiting firm providing expertise in a diverse range of professional disciplines and industries. Services include direct hire, contract and contract to hire. Locally owned and operated in north central Indiana with services provided across the USA. Focus, dedication and passion are at the root of everything we do - we are not just connecting the dots, but building lasting partnerships with our clients and candidates. To learn more about HireFocus Recruiting, email us at contact@hirefocusrecruiting.com HireFocus Recruiting is an equal opportunity recruiting firm. All qualified applicants will be given consideration regardless of race, color, religion, age, sex, national origin, disability status, protected veteran status, or any other characteristic protected by federal, state or local laws.