Quality Manager

Job Description

Position Purpose
The Quality Manager leads the Quality Assurance and Quality Engineering functions in Colorado and reports to the Director of Global Quality. Under the guidance of the Director of Global Quality, the Quality Manager is responsible for assessing the current and establishing an improved and effective Quality Management System to ensure the system meets regulatory and industry standards. They utilize an extensive set of quality skills to help drive continuous improvement, ensure the quality attributes of products are met, and develop highly skilled teams. They monitor quality metrics and report these up to senior management. They are the primary point of contact for second- and third-party audits and inspections, testing review and disposition, and customer complaints and investigations. This role forms partnerships with plant leadership to drive the success of the organization.

The Quality Manager oversees and manages the quality teams in Boulder, which includes Quality Engineering and Quality Assurance for Sievers analytical instruments and consumables. The Quality Manager will be responsible for product and process quality, Root Cause Analysis (RCA), and corrective actions from
manufacturing through customer issues in the field.
Duties & Responsibilities

• Build a high-performing quality team. Mentor, coach, train, and lead quality personnel. Perform administrative duties such as scheduling, performance reviews, hiring, budget, etc.
• Identify and document risks and gaps for applicable regulatory, ISO, and/or customer requirements. Keep management informed about risks and critical non-conformities. Under guidance from the Director of Global Quality, assess, recommend and establish an effective Quality Management System governing manufactured products and testing laboratories.
• Establish effective laboratory and quality processes to ensure the proper testing and release procedures are in place, including maintaining effective deviation, QOIs, and CAPA systems.
• Ensure that change control, standardization of work, training, deviations, CAPA, complaints, and audits serve organizational quality objectives and priorities. Author, revise, and update controlled documents, such as SOPs, forms, and charts.
• Ensure all requisite quality activities are executed as specified in a timely manner.
• Ensure proper maintenance and calibration of testing equipment.
• Oversee the review and disposition of non-conforming materials.
• Review controlled documents, change orders, NPI deliverables, test reports, etc for Quality compliance
• Preparation and review of clear concise audit reports that ensure mitigation of identified risks and that appropriate corrective/preventive action plans are implemented to address gaps in systems/processes and/or risks.
• Ensure effective maintenance of Certifications and Standards, including timely responses to findings and opportunities for improvements.
• Manage change controls and variations as appropriate.
• Investigate customer complaints using systematic methods and properly identify root cause and associated corrective and preventive actions.
• Partner with the corporate regulatory team regarding changes in industry and regulatory standards and advise on business impact.
• Ensure readiness of all quality activities incl. audits and inspections.
• Influence multiple stakeholders across Quality, Supply Chain, Aftermarket, Technology, and Product Development & Application departments as well as Suppliers and Customers.
• Use a pro-active mindset and ability to work with stakeholders to identify and resolve findings with solutions that are fit for purpose and ensure sustained compliance performance.
• Develop and report quality KPIs for instruments, consumables, and customer quality via a quality dashboard.
• Develop team skills to lead certification for ISO 9001, ISO 17025, ISO 17034, and ensure product regulatory compliance for all products in all target markets.
• Participate in proactive strategy development for the quality organization and innovate new ideas for quality improvement, reporting, compliance, and customer satisfaction.
• Coordinate quality improvement teams and mentor root cause corrective action investigations via a formal CAPA (Corrective Action Preventive Action) process
• Assist director of quality in development of operational and strategic plans for the quality organization including budgeting, resource needs, blueprint development, and prioritization of key quality programs

Qualifications

Knowledge Skills & Abilities

• Experience with manufacturing of analytical instrumentation.
• Prior experience with hosting regulatory inspections and development of CAPAs to address findings and preparation of formal response.
• Good knowledge of best Quality practices
• Prior experience calibration and testing of analytical instruments and testing of reference standards.
• Ability to read, write, and converse in the English language.
• Must follow ISO, PPE, and company safety policies in the performance of job duties.
• Proficiency with auditing process (both virtually and on site), for all external and internal quality audits.
• Ability to influence and collaborate effectively with stakeholders at any level of the organization.
• Analytical mind, good attention to details and problem-solving skills within a structured process.
• Concise and persuasive in the description and resolution of compliance risk.
• Understanding of corporate governance processes.
• Working understanding of R&D and New Product Development practices and requirements.
• Demonstrated application of continuous improvement, change control and risk assessment.
• Fluent in English – spoken and written.
• Manage and mentor college interns
• Interface with supplier quality management to drive supplier quality improvement
• Help develop and implement strategy for quality management system training
• Customer site visits to observe implementation and use of analytical instrument products
• 10 % domestic travel to customer or other company sites

Required:

• Bachelors degree in Chemistry, Microbiology, Mechanical Engineering, Electrical Engineering,  or biomedical engineering or equivalent experience in a relevant technical field
• 5+ years working with ISO 9001, regulatory, testing, and manufacturing requirements.
• Demonstrated knowledge and experience in performing ISO audits.
• Detailed knowledge of ISO 9001 standards and awareness of ISO 17025/17034 standards.
• Data collection, validation, and analysis

Preferred:

• Demonstrated knowledge establishing risk-based analysis.
• Continuous improvement, total quality control, lean six sigma experience
• Skilled in coaching, development, and performance feedback
• KPI and dashboard development and reporting