Senior Manager, Quality Systems

American Sterilizer Company (US)•Mentor, OH

9d•$124,738 - $154,088

About The Position

The Senior Manager, Quality is responsible for leading quality improvement for complex or multi-site manufacturing or service facilities. This position takes the lead in developing, adopting, and maintaining state-of-the-art quality practices for sites which have multi-faceted product/service lines and associated regulatory requirements. The Senior Manager, Quality 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 CFR Part 820/211, EU MDR and other applicable standards. This role leads the local site(s) efforts focused on product/service quality improvement, supplier quality, process quality, new product/service development quality and quality system compliance. The Senior Manager, Quality serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards.

Requirements

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 of 6 years in a Quality leadership role.
Must fulfil the experience requirements listed in Article 15 of the EUMDR (PRRC).
Excellent problem-solving skills
Focus on identification of potential issues and continuous improvement.
Experience working on cross-functional teams and on own initiative.
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.

Nice To Haves

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

Responsibilities

Lead the organization’s Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement.
Lead the organization’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 organization’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 organization’s Management Review process.
Ensure compliance with appropriate domestic regulatory and international standards and requirements.
Lead the organization'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.
Perform other duties as assigned.