The Global Quality Control Manager handles providing global leadership and direction and hands on operational support in quality control, analysis, and improvement. The Global Quality Control Manager develops and further enhances quality control initiatives consistent with established corrective standards, internal standards, customer specifications, legislative requirements, and production goals.
- Develop a clear global vision to the operational techniques and activities to fulfill requirements for the global quality strategy.
- Collaborate with internal resources including R&D and Operations to continuously improve quality outcomes through the development of quality policies and best practices.
- Monitor and reports on quality metrics and progress toward quality goals.
- Understands and can successfully develop and apply Statistical Quality Control (SQC) to the products.
- Understands and can successfully develop and apply Statistical Process Control (SPC) to the processes.
- Develop a global quality management system to drive best practices in quality system compliance and efficiency.
- Responsible for maintenance of document control, including release and changes (develop of structure and content, review and approval), for all QMS-related documentation such as quality manual, standard operating procedures, device master record (including test methods) and batch history records.
- Provide expert level guidance to IntelliGen leadership on quality improvement, problem solving, and recommendation using root cause analysis and best practice.
- Provide leadership to QA staff in establishing career development and appropriate training plans in the quality discipline and in enhancing skills in data analysis, risk management approaches, and investigations for root cause determination.
- Partner with operations team to implement quality control tools and process control to improve yields and reduce scrap.
- Ensure best practices across the global business and drive a quality culture to meet business performance criteria.
- Ensure clarity flows up, down and across the organization.
- Develop a high performing and engaged global quality team.
- Give concise executive summaries of quality issues, changes needed or made, results delivered.
- Effectively lead projects to conclusion while managing resources such as time, cost, and people.
- Bachelor’s Degree in Bacteriology, Microbiology, Molecular biology, life sciences or other applicable degree with life sciences experience
- Experience with biosystems manufacturing, molecular genetics or experience working with DNA based measurement technology or PCR based techniques.
- Experience in a lean manufacturing or quality environment.
- Experience working with regulatory compliance agencies.
- Experience in DNA assays to ensure optimization and efficiencies.
- Experience with change control, process control and quality system management.
- Must have experience with Metlab, DDPCR
- Demonstrated ability to lead high-performance and globally-dispersed team.
- Ability to manage change and projects effectively.
- Demonstrated effective written and verbal communication skills.
- More advanced experience with Microsoft Office products. Specifically, Excel, and PowerPoint.
- Strong interpersonal skills, achievement oriented, self-motivated, and organized.
Willingness to travel (domestic and international) up to 10% of the time.
Job Type: Full-time
- DDPCR: 1 year (Required)
- MetLab: 1 year (Required)
- Quality Control: 3 years (Required)