Senior Manager, Quality Systems

The Senior Quality Manager assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820. This role leads the local site(s) efforts focused on product/service quality improvement, supplier quality, new product/service development quality and quality system compliance. The Senior Quality Manager serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards. This position also takes the lead in developing, adopting and maintaining state-of-the-art quality practices for multi-site and complex product and service lines.

• Lead the business unit's Quality staff to ensure compliance to the overall Quality Management System and drive Continuous Improvement.
• Lead the business unit's Quality staff to ensure alignment to manufacturing and servicing operations, support Lean efforts and drive quality improvement for products and services.
• Work closely with Senior Management to provide strategic direction and development of the business unit's quality strategies and tactics.
• Provide quality viewpoints and opinions on future product and service development.
• Provide coaching, mentoring and leadership to the Quality staff.
• Serve as the site's Management Representative and lead the business unit's Management Review process.
• Ensure compliance with appropriate domestic regulatory and international standards and requirements.
• Lead the business unit's continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the product/service quality dashboard.
• Lead and develop effective production and process controls.
• Manage the complaint handling processes to insure customer responsiveness and product and process improvements.
• Ensure compliance to the New Product Development process and assurance that the Product Requirements Document includes key quality performance metrics.
• Assess new designs for manufacturability, testability and reliability to ensure the Quality risks and deliverables of the New Product Development process meet the required application reliability and design intent.
• Determine supplier qualification risks based upon criticality of component and supplier process capability.
• The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance.
• Perform other duties as assigned

Required:

• Bachelor's Degree (Engineering or related technical field)
• Minimum 10 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience
• Minimum 10 years of experience working in an ISO certified environment
• Minimum 6 years in a Quality leadership role
• Focus on identification of potential issues and continuous improvement
• Experience working on cross-functional teams and on own initiative

Preferred:

• Experience with statistical analysis software and Visio
• Minimum 10 years of experience with medical device or other regulated industries
• ASQ, QSR or familiarity with QSR/GMP regulations

Other:

• Excellent problem-solving skills
• Demonstrated excellent organizational, oral, and written communications skills
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

Here is a brief overview of what we offer:

* Market competitive pay
* Extensive paid time off and (9) added holidays
* Excellent healthcare, dental, and vision benefits
* Long/short term disability coverage
* 401(K) with company match
* Maternity and parental leave
* Additional add on benefits/discounts for programs such as pet insurance
* Tuition reimbursement and continued educational programs
* Excellent opportunities for advancement in a stable long-term career

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