The Executive Director or Director of Quality Management & Regulatory Affairs at Company will lead the Quality and Regulatory function, and will be responsible for establishing, implementing, and continuously improving a best-in-class local quality & regulatory management and assurance program aligned and consistent with the Company Corporate guidelines.
- Manage a staff of Quality & Regulatory Engineers, Inspectors, and Technicians, and function as a leader and a coach to direct and indirect reports. Manage the team through the established functional goals and objectives and hold team members accountable. Ensure all training requirements are met for the staff and documented.
- Establish and champion a strong culture of bringing focus to Cost for Poor Quality through effective communication, training and continuous process improvement with our manufacturing teams and all other stakeholders.
- Develop effective partnerships with key stakeholders across the Company Matrix functions (below) to improve product quality and quality systems performance through assessments of best practices and benchmarking
- Corporate Quality Management/Regulatory function
- Quality teams across various manufacturing plants and R&D centers
- Operations functional leaders
- Product managers
- Identify and maximize opportunities to use information and technology to improve processes, productivity, and efficiency
- Implement a balanced scorecard that encompasses both operational and financial metrics internally as well as with suppliers for supplier quality, audits, and inspections
- Develop and manage departmental budgets accordingly
- Develop, improve and execute the Quality Management (QM) System (ISO 9001 and 13485) according to Company Matrix QM system including incorporation of global standards into Local guidelines
- Perform internal audits in order to ensure compliance with processes, roles, responsibilities and workflows
- Establish quality objectives for products and processes reflecting Company's strategic and tactic goals
- Train COMPANY workforce according to current QM guidelines
- Establish and lead the quality management reviews, implementing the necessary changes to continuously drive systems and process improvement throughout the organization. Coordinate the preparation, review and approval of quality management metrics, quality reports, and KPI's. Serve as management representative to stakeholders for critical corrective actions and recurring quality status reviews.
- Actively collaborate with R&D leadership and teams to ensure systems and processes are developed and implemented to ensure quality is designed into new products. Ensure potential quality & regulatory risks are actively assessed, managed, communicated, and addressed appropriately during the product development process and milestones. Performs critical review of Engineering Change Orders (i.e. Documentation and Engineering) related to Quality System and Regulatory requirements.
Quality Assurance / Quality Control
- Establish efficient and effective inspection systems and processes for incoming components from suppliers to achieve high throughput and productivity, while maintaining high accuracy and quality standards. Serve as an interface on quality topics with supplier quality teams regarding incoming product and component quality issues and ensure compliance. Work with the local Purchasing, manufacturing, engineering, and R&D teams to ensure corrective actions are implemented in timely manner.
- Develop and drive Quality initiatives that effectively address manufacturing and product quality issues. Support manufacturing teams in resolution of customer quality problems related to assembly, process and product function by driving robust corrective actions and change in processes.
- Work directly with all functions to ensure that inspections, statistical process control analyses, metrology calibrations, and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. Conduct internal quality assurance audits and effectively and drive root cause analysis and corrective actions to reduce repeat occurrences.
- Establish quality systems and directives for manufacture of Bioprocess Bench/Pilot Production equipment and consumables such as product & process validation, cGMP documentation and genealogy support, Pressure Equipment Directives (PED), and ensure necessary compliance.
- Develop, implement, and improve regulatory compliance of products, processes and documentation according to system specifications as well as current global directives.
- Ensure regulatory compliance of products and processes during full product lifecycle
- Bachelor's Degree in Engineering required (preference for Electrical, Mechanical, or Chemical); Masters or another technical graduate degree highly preferred
- 15 or more years of progressive experience in Quality Management required (including seven or more years in the manufacturing quality environment required)
- Seven or more years of experience in progressive leadership roles required
- Experience in a high-level quality leadership role (Director, Sr. Director or equivalent) required with proven ability to bring Systems Level Thinking and Process driven implementation across the organization.
- Proven track record of leading effective change initiatives and quality management development
- Work experience in laboratory equipment manufacturing (Life science equipment such as centrifuges, shakers, freezers, bioprocess reactors and controllers) environment preferred
- Extensive experience with quality techniques: Design and Process FMEA, SPC, etc.
- Well versed with regulatory standards such as IEC 61010, ASME, Pressure Equipment Directive (PED)
- Six Sigma, Certified Quality Engineer (CQE), Certified Manager of Quality/Operational Excellence (CMQ/OE) certifications preferred
- Strong verbal and written communication skills, emphasizing interpersonal, group presentation, and team facilitation skills. Ability to confidently present to the Executive Management and Board of the company.
- Ability to travel occasionally ? domestic as well as international