Quality Manager

• Support a strong culture of compliance related to Safety Environmental and Quality standards
• Ensure all processes procedures and outputs meet ISO 13485 FDA and internal quality standards.
• Coordinate and support ISO 13485 certification activities and all internal customer and regulatory audits.
• Partner with the Director of Quality & Regulatory to support regulatory strategies and ongoing compliance efforts.

• Demonstrate a strong commitment to the organizations Mission Vision and Core Values.
• Support a company culture dedicated to safety continuous improvement employee growth and well-being.
• Participate in and support risk management activities across all stages of design manufacturing and product lifecycle.
• Proactively identify regulatory quality and operational risks and lead mitigation strategies.

• Manage day-to-day Quality Control and Quality Assurance activities in alignment with established QMS requirements.
• Administer and continuously improve document control and configuration management systems.
• Review support and coordinate investigations nonconformances and CAPA in partnership with the Quality & Regulatory team.
• Support Management Review activities by preparing inputs data analysis and follow-up actions related to the QMS effectiveness

• Track analyze and report Quality KPIs to support leadership decision-making and regulatory requirements. Support initiatives to reduce out-of-box failures customer complaints and quality-related losses.
• Apply quality improvement tools and methodologies to increase productivity consistency and customer satisfaction.
• Assist in the development and implementation of new quality standards including manual and automated test procedures.

• Collaborate with Engineering Manufacturing Supply Chain and Operations to support product development process improvements and new product introductions.
• Support reliability engineering failure analysis supplier quality quality engineering and auditing activities.
• Participate in quality support for GMP manufacturing capabilities as required.

• Support the development and day-to-day management of Quality & Regulatory team members.
• Assist with setting clear departmental goals aligned with organizational priorities.
• Maintain open communication through regular one-on-one and team meetings.
• Support a compliant effective training program for all employees.

• Support departmental resource planning and budget tracking.
• Help ensure staffing tools and systems align with quality and regulatory needs.

• This position may provide day-to-day work direction coaching and support to Quality and Regulatory team members and may participate in hiring training performance management and employee development activities in accordance with company policies and applicable laws

• Always prioritize safety and actively demonstrate safe practices in every task. Follow all safety procedures proactively report unsafe situations and wear the required PPE.
• Lead by example in maintaining a safe work environment and encourage your co-workers to do the same.
• A passion for working in a fast-paced safety-oriented mission-driven manufacturing environment.
• Demonstrated leadership experience in a regulated quality environment.
• Strong working knowledge of ISO 13485 International Standard CMDCAS FDA EU regulations/directives and other international regulations as required.
• Proven ability to lead compliance audits and continuous improvement initiatives.
• Strong customer focus with the ability to work independently and follow tasks through to completion.
• Excellent organizational prioritization and problem-solving skills.
• Strong interpersonal skills with the ability to collaborate effectively across departments.
• Experience with Quality System documentation and good documentation practices.
• Active ASQ membership is desirable.
• Excellent written verbal and presentation communication skills.
• Ability to present information to all levels of employees and partners.

• Bachelors Degree in Engineering Chemistry Biology or a related technical discipline.
• Minimum of 5 years of experience in an FDA-regulated pharmaceutical biotechnology or medical device environment. Previous engineering experience in a medical device market preferred.
• At least 5 years of Quality Assurance experience.
• Or an equivalent combination of education and experience.
• Alternate education and experience considered based on the individual candida

Physical and Work Environment Requirements:

• Office and Manufacturing Environment with a strong focus on safety and quality.
• PPE is required in designated areas.
• Combination of sitting standing and moving throughout the facility during the workday
• Ability to frequently lift or move materials up to 25 pounds.

• Strong computer skill required for documentation and training.
• Proficiency in MS Office Suite
• Experience with document management and ERP systems.
• Adobe Acrobat required.

Travel Requirements:

• Occasional local travel during the business day mostly between facilities.

• Be part of a mission-driven company helping make people safer healthier and more productive.
• Know that your leadership directly impacts the safety and reliability of products used in laboratories by healthcare providers and by patients worldwide.
• Join a team that takes pride in craftsmanship quality and doing work that truly matters.
• Lead and develop high-performing teams within a collaborative environment that values continuous improvement and operational excellence.