Nolato GW is a global leader in precision injection molding and contract manufacturing for the world’s most successful healthcare, automotive, and industrial OEMs.
Join an organization that is respected throughout the industry for our advanced technology, quality, and innovation – all while enjoying the benefits of stable ownership, a collaborative culture, professional development, continuing education, global opportunities, and an exceptional benefits package.
Director of Quality Assurance and Regulatory Affairs
President and CEO
The Corporate Director of Quality and Regulatory Affairs (CDQRA) is responsible for establishing the strategic direction for continuous quality improvement and the implementation of quality policies for Nolato GW global locations. This position will be responsible for leading Nolato GW quality assurance and regulatory affairs efforts across all Nolato GW facilities.
The CDQRA will benchmark best practices for the sustained improvement of critical quality and business processes throughout the corporation. The CDQRA works with senior management to identify areas of improvement, creates projects, gathers resources to work on projects, and manages the progress of projects to support the company’s short and long-range business objectives. This individual will oversee the deployment of quality analysis tools and will act as a resource for front line Quality Managers, Executive Management and other members of the Management Team.
The CDQRA will coordinate, guide and lead on issues and initiatives, which bridge multiple plants to bring continuity to the management of Quality systems throughout the organization. The position requires frequent direct interface with customers. Overnight travel may be required up to 50% of the time. This position is located at Nolato GW’s headquarters in Bethel, Vermont.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead company-wide initiatives related to developing, implementing, streamlining all manufacturing Quality Control, manufacturing quality polices and release of all key programs into production.
- Refine and troubleshoot GW Nolato’s existing policies and procedures to best fit the company’s corporate quality Assurance/Control needs.
- Lead company SPC efforts while promoting standardization among plant practices, documentation, and systems related to Quality, Manufacturing and liaison between Engineering and the plants new products and launches.
- Lead ISO 13485, and FDA’s Title 21 CFR’s including 21 CFR part 820 and 14971 risk management.
- Direct medical/FDA guidelines and GMP culture implementation on the manufacturing floor.
- Mentor manufacturing teams and others on process improvement philosophy, tools and application.
- Provide QC, GMP and medical device expertise to advance Nolato GW’s medical device assembly and contract manufacturing business.
- Support New Program Launch Design Review Meetings and engage with project teams on IQ/OQ/PQ activities including FMEA and Control Plan review to ensure consistency and assist with transfer of new products from engineering to the manufacturing floor.
- Review and/or negotiate customer-specific requirements and manuals to ensure that Nolato GW systems comply with such customer expectations.
- Actively support layered audit programs, by personally conducting quality system and process-level audits at various GW Nolato locations.
- Annually perform Quality Planning to establish GW’s KPI Objectives.
- Work directly with QA Managers to promote a Zero defect and continuous improvement and GMP culture.
- Work with Senior Manager of Regulatory Affairs to help prepare and support FDA audits as needed.
- Work with Senior Manager of Regulatory Affairs to identify key systems to reduce documentation workload to allow key positions to monitor floor better.
- Mentor and develop plant personnel (Quality Technicians, Specialists, and Manufacturing Quality Engineers) training programs and champions ISO13485 certification audits, training, and maintenance within all facilities.
- Manages the Material Review Board CAPA weekly review of key customer within Nolato GW facilities.
- Improves quality control manufacturing systems plant-wide to achieve zero defects through hands-on training, strong work ethic, and leadership by example.
- Identifies and resolves systemic quality problems at both plant level through a reduction in variation in processes and components (i.e., SPC, SQC, Pareto charts, GEMBA walks, etc.)
- Maintains and enhances plant level quality performance metrics, sets goals for Quality KPI.
- Participates in Quality Flash meetings with other Nolato GW plant managers and quality managers.
- Improves profitability through reduced internal scrap and customer returns
- Successfully interfaces with key customers and prospects to improve quality and win new business (specifically Johnson & Johnson and key customers to Nolato GW).
- Effectively work with Engineering Managers and Advanced Quality Engineers to ensure PQ runs are successful and uses early production containment to provide feedback to the Engineering team(s).
- Perform other related duties as assigned.
To be successful, an individual must be able to perform each essential duty above, with or without reasonable accommodation. The requirements listed below are representative of the knowledge, skill, and /or ability required to successfully carry out the duties and responsibilities of this position:
- Executive level individual with documented quality management success within a medium to large multinational company. Understanding of a matrix organizational structure is helpful.
- Proven hands-on leadership experience. Able to effectively drive initiatives through persuasive and inspirational leadership. Proven ability to encourage active participation by forming cross-functional teams.
- Able to develop a GMP culture with hands-on enforcement.
- Successful FDA audit experience.
- Able to identify problems and communicate solutions in a constructive and positive manner.
- Excellent customer communication skills for managing interactions at all levels in the customer’s organizations.
- Excellent written and verbal communications skills. Strong project management and multi-tasking skills.
- Proficiency with Microsoft Office and Quality Management Information Systems.
- Able to thrive in a lean and fast-paced, high-growth environment.
- Comfortable with strategic planning as well as with hands on roles, which will require working on the production floor and in other manufacturing/ warehouse environments in addition to an office environment.
- Practitioner level Lean Manufacturing experience with a record of accomplishment in leading Kaizen events, VSM and overall process improvement activities.
- ASQ Certified Quality Engineer, Quality Auditor, Quality Manager, Six Sigma Black Belt or similar achievements preferred.
- BS in Engineering, Math or equivalent preferred.
- 10-15 years’ related experience in Healthcare contract manufacturing, training, quality and/or consulting roles. Strong preference given to candidates with experience in precision plastic injection molding and healthcare medical device, pharmaceutical and drug delivery contract manufacturing.