Standard BioTools
Manager, Quality Assurance
Standard BioTools, Boulder, Colorado, United States, 80301
Would you like to join an innovative team driven by a bold vision - unleashing tools to accelerate breakthroughs in human health?
This position will lead the quality team in the implementation and continuous improvement of the Quality Management System and quality assurance functions at Standard BioTools, Boulder, including lab quality, production & process controls, design controls, CAPA subsystem including complaints management, and overall QMS continuous improvement. The Quality team supports a broad range of regulatory and quality requirements across multiple international markets, from CLIA testing and Lab Developed Tests (LDT) to software. The individual in this role will be a key leader in the company's quality strategy and will be relied upon to address and implement new and developing quality standards and regulatory requirements
Key Job Responsibilities
Manage, monitor and direct the company's Boulder site quality system that is aligned with the strategic needs of the business. As part of this position, you'll be responsible to:
• Lead the quality operations functions for laboratory quality including paperwork review, report release, NCR review, change control, process improvements
• Lead the quality operations functions for design controls and risk management including assessments of change controls including participation in new product development, design validations and design transfers per the company's New Product Development process.
• Lead the quality operations functions for QMS under ISO 9001:2015, including Document Controls, Audits, Training, Management Review, and Production review and release of materials and products
• Lead the quality operations functions for the CAPA Subsystem including post-market surveillance and vigilance, CAPA process and continuous improvement
• Develop and continuously improve upon the quality management system (QMS) of Standard BioTool Inc.
• Establish procedures and manage the organization for QMS for compliance to ISO 9001, ISO 15189 and regulations as required by the product and our customers
• Serve as the management representative to ensure that the quality system requirements are effectively established and maintained and reports the performance of the quality system to management with executive responsibility.
• Be part of the Company's global quality management team representing Boulder site.
• Represent the Quality function and manage personnel on core teams for projects, providing quality guidance on local and international regulations, requirements, and compliance documentation in support of purchasing, manufacturing, laboratory, and commercial operations.
• Lead quality product & process improvement activities as part of the overall quality system effort.
• Coach and mentor team members to create an environment that builds team engagement and fosters career development and growth opportunities.
• Work with the team to set individual and team goals and monitor progress regularly.
• Support certification initiatives and lead quality audit programs as needed, including the company's internal audit program.
• Ensure respective team members are competent to perform their respective roles and responsibilities per procedures and training plans.
Qualifications
Education: Sc./M.Sc. in Physical Sciences, Engineering or Biology
Quality certifications (CMQ/OE; CQE; CQA or Six Sigma Black belt) desirable
Skills and experience
• 5+ years (4 years with Master's Degree) in a Quality function within a related field (lab, pharma, or medical device) with at least 5 years' experience managing a quality team. Experience in In Vitro Diagnostics is preferred.
• Experience with and clear understanding of ISO 9001:2015, 21 CFR Part 820, ISO 13485:2016, and ISO 14971:2019 is required. Experience with CLIA regulations, ISO 15189:2012 standard, and 21 CFR Part 11 compliance is highly preferred
• Experience in deploying and implementing Quality Management System processes is required with experience with new QMS certification.
• In depth knowledge and/or formal training in quality principles and technical tools (Quality Systems, Lean, problem analysis, statistical tools, design of experiments, design for six sigma, control charts and other quality methodologies) with the ability to train and provide consultation.
• Experience with an ISO 13485 and FDA compliant design control, change control, process control and quality system management related to medical devices.
• Demonstrated computer skills (word processing, spreadsheets, graphics, statistical tools).
• Experience in setting strategic direction while analyzing problems and improve products and processes.
• Experience in providing concise executive summaries of quality issues, changes needed or made, results delivered.
• Strong leadership and interpersonal skills, sound judgement, strong analytical skills, problem solving and excellent written and verbal communication skills
• Experience with implementation and maintenance of electronic document control and quality management systems (Arena PLM, ComplianceQuest).
Work Environment
• Work is in typical office environment but may require occasional work in a typical laboratory environment with personal protective equipment use required.
• Ability to be on-site minimum 3 days a week.
• This position may require up to 10% travel. Some of the travel is international.
• As Standard BioTools Inc. is a Hazardous Waste Generator, this position performs hazardous waste duties in accordance with internal controlled documents, local, State and Federal regulations.
This position will lead the quality team in the implementation and continuous improvement of the Quality Management System and quality assurance functions at Standard BioTools, Boulder, including lab quality, production & process controls, design controls, CAPA subsystem including complaints management, and overall QMS continuous improvement. The Quality team supports a broad range of regulatory and quality requirements across multiple international markets, from CLIA testing and Lab Developed Tests (LDT) to software. The individual in this role will be a key leader in the company's quality strategy and will be relied upon to address and implement new and developing quality standards and regulatory requirements
Key Job Responsibilities
Manage, monitor and direct the company's Boulder site quality system that is aligned with the strategic needs of the business. As part of this position, you'll be responsible to:
• Lead the quality operations functions for laboratory quality including paperwork review, report release, NCR review, change control, process improvements
• Lead the quality operations functions for design controls and risk management including assessments of change controls including participation in new product development, design validations and design transfers per the company's New Product Development process.
• Lead the quality operations functions for QMS under ISO 9001:2015, including Document Controls, Audits, Training, Management Review, and Production review and release of materials and products
• Lead the quality operations functions for the CAPA Subsystem including post-market surveillance and vigilance, CAPA process and continuous improvement
• Develop and continuously improve upon the quality management system (QMS) of Standard BioTool Inc.
• Establish procedures and manage the organization for QMS for compliance to ISO 9001, ISO 15189 and regulations as required by the product and our customers
• Serve as the management representative to ensure that the quality system requirements are effectively established and maintained and reports the performance of the quality system to management with executive responsibility.
• Be part of the Company's global quality management team representing Boulder site.
• Represent the Quality function and manage personnel on core teams for projects, providing quality guidance on local and international regulations, requirements, and compliance documentation in support of purchasing, manufacturing, laboratory, and commercial operations.
• Lead quality product & process improvement activities as part of the overall quality system effort.
• Coach and mentor team members to create an environment that builds team engagement and fosters career development and growth opportunities.
• Work with the team to set individual and team goals and monitor progress regularly.
• Support certification initiatives and lead quality audit programs as needed, including the company's internal audit program.
• Ensure respective team members are competent to perform their respective roles and responsibilities per procedures and training plans.
Qualifications
Education: Sc./M.Sc. in Physical Sciences, Engineering or Biology
Quality certifications (CMQ/OE; CQE; CQA or Six Sigma Black belt) desirable
Skills and experience
• 5+ years (4 years with Master's Degree) in a Quality function within a related field (lab, pharma, or medical device) with at least 5 years' experience managing a quality team. Experience in In Vitro Diagnostics is preferred.
• Experience with and clear understanding of ISO 9001:2015, 21 CFR Part 820, ISO 13485:2016, and ISO 14971:2019 is required. Experience with CLIA regulations, ISO 15189:2012 standard, and 21 CFR Part 11 compliance is highly preferred
• Experience in deploying and implementing Quality Management System processes is required with experience with new QMS certification.
• In depth knowledge and/or formal training in quality principles and technical tools (Quality Systems, Lean, problem analysis, statistical tools, design of experiments, design for six sigma, control charts and other quality methodologies) with the ability to train and provide consultation.
• Experience with an ISO 13485 and FDA compliant design control, change control, process control and quality system management related to medical devices.
• Demonstrated computer skills (word processing, spreadsheets, graphics, statistical tools).
• Experience in setting strategic direction while analyzing problems and improve products and processes.
• Experience in providing concise executive summaries of quality issues, changes needed or made, results delivered.
• Strong leadership and interpersonal skills, sound judgement, strong analytical skills, problem solving and excellent written and verbal communication skills
• Experience with implementation and maintenance of electronic document control and quality management systems (Arena PLM, ComplianceQuest).
Work Environment
• Work is in typical office environment but may require occasional work in a typical laboratory environment with personal protective equipment use required.
• Ability to be on-site minimum 3 days a week.
• This position may require up to 10% travel. Some of the travel is international.
• As Standard BioTools Inc. is a Hazardous Waste Generator, this position performs hazardous waste duties in accordance with internal controlled documents, local, State and Federal regulations.