The Senior Manager, Quality Control will develop, implement, and maintain the activities of the Quality Control department to support Manufacturing Operations and Supply Chain by administrating incoming, in-process and release testing through an organization of Quality Control professionals. The Manager, Quality Control will make recommendations and investigate corrective actions necessary in regards to material non-conformances and out of specification results to ensure conformity with quality specifications. This role will manage projects, and assign resources to individual tasks as required.
- Manages the activities of the quality control department to create a culture of quality awareness, teamwork, and cooperation with all departments within the Facility.
- Assures compliance with Quality System Regulations and ISO regulations within the quality control department.
- Conducts trouble shooting investigations and product support activities for in-house production and for customer requests.
- Improve the customer experience regarding initial quality and long term reliability by working issues to root cause and implementing robust corrective and preventative action plans. This will likely involve strong cross functional skills to arrive at consensus as to most effective solution and implementation plan.
- Ensures compliance with applicable laws and regulations including processes and systems related to cGMPs.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
- Monitor and trend quality data; ensure periodic cross-functional reviews, of quality metrics and implement corrective actions against adverse trends and non-conformances.
- Identify and support Practical Process Improvements (PPI) initiatives within the quality control department.
- Provides career development and training to direct reports.
- Work with R&D to ensure product manufacturability and product reliability issues are addressed in the design stage of new product development
- Management and oversight of quality instrument maintenance.
- Prepares yearly training schedules for the department and perform periodic employee reviews.
- Establishes and Maintains SPC for new and existing products.
- Bachelor of Science in Chemistry, Biochemistry, or Bioscience, Masters preferred.
- Over 10 years Quality Assurance/Quality Control experience, preferably in the medical diagnostics/pharmaceutical industry.
- Minimum of 5 years of direct supervisory experience.
- Experience leading quality initiatives.
- Ability to analyze data, summarize results, troubleshooting issues, and identify solutions
- High level of communication and presentation skills, with strong word processing and spreadsheet software skills.
Non-Negotiable Hiring Criteria:
- The position does not offer Relocation Assistance.
- Strong command of Quality System Regulations and ISO.
- Experience with project management and process improvement practices.
- Excellent organizational skills to manage multiple tasks simultaneously.