Job Description

Quality Manager

Cytonome, LLC. – Lexington, MA

Job Overview

Cytonome is a subsidiary of the global STgenetics group, an international leader of livestock reproductive services. Cytonome is based in the heart of the Massachusetts technology corridor and has additional research and development (R&D) teams in Texas and New Zealand. In 2021, we expanded our software capability via acquisition of Verity Software House, the cytometry software experts.

Our facilities include an ISO 8 cleanroom for GMP consumable manufacturing, biological laboratory facilities (BSL2), and extensive engineering and R&D facilities.

Cytonome operates under a quality management system compliant to ISO 9001:2015 and ISO 13485:2016

We are seeking an experienced Quality Manager to add to our team. As the Quality Manager, you will be responsible for delivering safe, reliable, compliant, and quality products that meet customer expectations.

Reporting to the General Manager of Operations, you will be responsible for leading all quality, manufacturing, and operation functions at Cytonome. This role involves ensuring products meet stringent quality standards, improving operational efficiency, and implementing technical solutions to enhance product reliability and performance. The successful candidate will be focused on driving continuous improvement to ensure products are manufactured and delivered on time and with the highest levels of quality.

Primary Duties and Responsibilities Include:

• Quality Strategy: Develop, implement, and manage a comprehensive quality strategy that aligns with the company's mission and objectives, ensuring continuous improvement in quality and overall operational efficiency.
• Quality Systems: Manage the quality management system, including ongoing re-certification of ISO9001, and internal and external (customer) audits.
• Operations: Lead the Operations department to ensure products and processes meet defined quality requirements, customer expectations, and on-time delivery metrics. Ensure all finished goods meet product requirements before shipment.
• Metrics: Develop and monitor key quality and operational performance metrics, utilizing data-driven insights to drive process and product improvements that will support growth and scalability.
• Supplier Quality Management: Collaborate with supply chain and procurement teams to establish and maintain supplier quality standards and ensure the integrity of the supply chain including the development of a robust incoming part inspection program.
• Regulatory Compliance: Stay abreast of all relevant regulations and standards (e.g., FDA, ISO, CE) and ensure that all quality processes and systems meet or exceed these requirements.
• Risk Management: Implement robust risk management practices throughout the product lifecycle and quality system, identifying potential risks and mitigating them effectively.
• Audits and Inspections: Oversee supplier quality audits and inspections, ensuring compliance with all relevant regulations and standards.
• Continuous Improvement: Champion a culture of continuous improvement by promoting Lean and Six Sigma methodologies, fostering a proactive approach to problem-solving.
• Design Quality: Collaborate closely with Engineering to drive design and process improvements that enhance product quality and performance.
• Communication: Effectively communicate quality and operational goals, progress, and challenges to senior leadership and cross-functional teams.

Supervisory Responsibilities:

• Lead and supervise staff; manage the performance of the quality and operations team.
• Coach, grow, mentor, and develop the quality and operations team.
• Identify and support professional development needs and/or goals and seek strategies to address them.
• Performance management: conduct performance reviews and resolve performance issues.
• Preparing reports by collecting, analyzing and summarizing data
• Working according to deadlines for the delivery of products
• Training and managing production line staff in production practices and quality assessment of goods
• Tracking products through the manufacturing process to guarantee that each part of the process is correct
• Performing detailed and recorded inspections of final products so the products are up to industry and company standards
• Eliminating products that are not up to standards and finding the reasons for product problems
• Immediately report concerns regarding the health, safety, or welfare of individuals or coworkers resolve conflicts and establish a sense of team within the unit.

Experience and Technical Requirements:

• Minimum of 5 years of progressive quality management experience.
• Proven track record of successful leadership in a global quality organization.
• Thorough understanding of regulatory requirements and quality ISO standards relevant to analytical instrumentation manufacturing or related devices.
• A growth mindset approach, with a track record for understanding changing methodologies that will yield continuous improvement.
• Strong analytical and problem-solving skills with Lean and Six Sigma experience.
• Excellent leadership, communication, and interpersonal skills.
• Ability to work collaboratively in a cross-functional environment.
• Certified Quality Manager certification is a plus.
• At least 5+ years of managerial experience.

Education Level:

• Bachelor's degree in a relevant field, preferably in Engineering, with 5+ years professional experience.

Physical Requirements (heavy lifting, ability to work in a laboratory, etc.):

This position involves working in and moving around an office environment, lab and assembly production environment. It involves extensive use of a computer. This role involves constant communication with employees, vendors, contractors, and business stakeholders. On occasion, work outside of regular business hours may be required.

With or without reasonable accommodation, able to:

• Work in office environment
• Use telecommunication tools
• Work in an engineering assembly production environment

Benefits:

We offer a complete benefits package, including medical, dental, vision, life insurance, 401k matching, paid time off, parental leave, and corporate wellness programs - all eligible on date of hire

Cytonome excels in creating a workplace where imaginative thinkers can participate in a stimulating entrepreneurial environment and contribute to a highly motivated, success-driven team. Cytonome is an equal opportunity employer. The stated policy of the Company prohibits unlawful discrimination on the basis of race, sex, sexual orientation, religion, color, national origin, age, disability, citizenship, pregnancy, veteran status, or other characteristics protected by federal, state, and/or local law.

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