Quality Director

Quality Director

Our client has been a privately held, family-owned business since 1984 until its recent acquisition by a publicly held Michigan based company. Our client has created a very employee friendly environment that fosters teamwork and respect. In 2006 our client transitioned from an automotive supplier to a prototype and customer manufacturer in the medical device space and business is strong! Our client is a leader in tooling and injection molding solutions for prototype, short run, and low to mid volume production applications. In this role, reporting to the President, you will manage a team of 7 in a 3 shift custom injection molding manufacturing environment.

As Quality Director you will:

• Develop, implement, and evaluate the current Quality Management System
• Ensure the effectiveness of the QMS to meet 21CFR820, ISO13485:2016 and client requirements
• Identify deficiencies, corrective actions, and continuous improvement initiatives
• Collaborate with all levels of the organization to develop positive and proactive approaches to compliance activities
• Be the Audit Lead for third party certifications/audits
• Manage internal and supplier audit programs

As Quality Director your background should include:

• Bachelor's degree in Engineering, Quality Services, Biology, Physics, Chemistry or Math
• Minimum of 10 years of experience as a Quality Manager/Director in the medical device industry
• Injection molding experience a plus
• Experience with ISO-13485 standards and 21CFR-820 regulatory compliance activity
• Risk assessment and Mitigation Planning experience with ISO-14971 and/or Design/Process-FMEAs
• Strong clients interaction skills
• Negotiating skills
• Development of Quality Plans and/or Control Plans
• Use of metrology and statistical analysis methods. Strong statistical background a must.
• Excellent oral and written communication skills.