Regional Quality Manager-North America
Skills, Experience and Education
Function as the quality lead for North America (NA), aligning the Customer Experience with corporate and regional business and product strategy. Assist the organization with prioritizing activities and focusing on continuous improvement of our products and processes.
Serve as the local product line subject matter expert from both a business and technical perspective.
Your core duties and responsibilities will be as follows (including but not limited to):
1. Function as the Quality Lead in representing NA requirements and customer needs
2. Quality Management responsible for measuring, monitoring and driving compliance and improvement in the NA region.
- Management Operating System (MOS) Quality key metrics (KPI) – Coordinate with the local plants aligning with the regional and corporate objectives and goals.
- ISO 9001 Certification - Monitor and support local plants in system implementation, optimization, improvement and 3rd party certification compliance. Includes internal audit to support the sites.
- Complaints (Customer, Internal, Supplier Corrective Action)
o Ensure compliance and use of system including timely entry by case workers and updating status and actions by the sites
o Actively engage the local site response coordinators in timely containment actions, root cause investigation, corrective action and communication with the customer
o Coordinate with the site response coordinators on proper prioritization and escalation to Regional Quality, Corporate Quality and associated GCP organizations.
o Escalated complaints – lead the complaint investigation and coordinate with the appropriate site management team.
- Problem Solving Methodology - Lead and train individuals and teams in DMIAC and Sologic RCA approach.
o Promote the application of statistical techniques including but not limited to GR&R, SPC, DOE, etc
- Product Certifications 3rd party (CE, BBA, etc)
o Quality System - Define system compliance requirements and monitor 3rd party audits and findings related to the plant certification. Track non-compliances responses for effective and timely closure by plant for the region.
o Product certification - Define product re-test and re-certification for compliance to specification. Develop a system to measure timely testing and open product compliance issues.
o Product Label Requirements related to certification – Responsible for assuring compliance to the marking, label, document requirements are met, including changes and updates
o Documentation and Records – Manage the control and retention and supporting documentation, including
§ Initial certification documents (i.e. Factory Production Control, Declaration of Performance, etc)
§ Records of test
o Communicate directly with the certification bodies when appropriate.
- Product Scale up - Provide quality technical support.
o Assist in identification to product and process Critical to Quality (CTQ),
o Support plants in defining and implementing a product and process Control and Inspection plan
- Raw Material and Tolled Goods Specifications
o Participate in development of the requirements from Quality perspective
o Assure the requirements are attainable and measure the CTQ product performance requirements
o Establish a process to verification and validation
o Products maintained under a 3rd party certification – Establish a system to verify compliance and ongoing re-certification
· Strong team leadership
· Excellent decision-making and problem-solving skills
· Ability to influence without direct reports
· Strong overall business acumen with a mindset for continuous improvement and productivity
· Good communication and team player skills
· Innovative and passionate about the product line
· Quality management experience in manufacturing environment
· Management of an ISO 9001 certified Quality Management System (QMS)
· Management of internal and external audits
· Project management skills working in a multi-cultural matrix organization
· Team leadership in quality improvement activities and problem solving using DMIAC and 6 sigma methodology
· Maintaining site Product Certification programs such as CE, BBA, etc
· Bachelor degree – Technical discipline
· 6 Sigma Statistical Analysis and Problem Solving tools
· ISO 9000 Auditing Certification (or equivalent experience)