Sable Systems International
The Quality Systems Executive Manager establishes, documents, implements and maintains the integrity and effectiveness of the quality management system in accordance with the requirements of ISO 9001:2015, ISO 13485:2016 and Environmental Health and Safety. She/he will develop and lead a culture of conscientious improvement. This Executive Manager will be the first-line contact with all regulatory agencies and will provide guidance to the executive and mid-management leadership in the assurance of compliance that meets the industry’s best practices. Responsibilities include regulatory compliance, employee training, facilitation of regulatory audits/inspections and driving the company's quality initiatives that may include the safety elements of product realization, personnel, and resource use. Results expected: efficient, rigorous and seamless quality process management expediting operational effectiveness to support company strategies.
- To live the value that an ounce of prevention is worth a pound of cure; to translate ‘productive paranoia’ to financial profit and optimism.
- Approachable hands-on style with the ability to engage with people at all levels of management.
- Dedicated to learn the values that incentivize the customer as fundamental to a quality (user) experience code of ethics for quality assurance management.
- Exhibits a high degree of technical knowledge, credibility and communicates highly technical information in a simplistic and easily understandable way.
- A Communicator! Excellent interpersonal, verbal, and written communication skills a level appropriate to the audience and the project with careful attention to detail and accuracy. Data-driven.
- Under-promise and over-deliver.
- Anticipate solutions before problems occur.
- To demonstrate to others that continual learning and adaptation to change creates an agile response when joined with documentation and instruction.
- Actively lead internal evaluations of processes to identify process control points, improving the effectiveness and efficiency of lean quality assurance processes.
- Direct the day-to-day activities of the Quality Management Team and ensure all activities are performed in accordance and in compliance with Company Values, Quality Assurance, and Health Safety policies.
- Oversee training and onboarding to Quality Management Systemswith ISO 9001:2015 and to WEEE, RoHS and similar regulatory international standards.
- Provide direction, supervision, and guidance to Company Leadership to ensure alignment with quality policy, strategic objectives and organization goals that drive a quality-proud culture – between Departments and within them.
- Enable appropriate Leadership to investigate problems and develop disposition and corrective actions process optimization and modifications for recurring discrepancies; Improve and maintain the Sable Systems cross-functional Non-Conformity Process.
- Delineate documentation roles and accountabilities.
- Develops a system to analyze and evaluate the root cause/s of quality discrepancies in data and from employees.
- Review the customer support process, working with the Chief Revenue Officer and the Technical Support Manager.Align projects within and between Departments to enhance the company’s quality and safety presence from beginning to end, fulfilling the company’s brand promises.
- Assess the input to and the output from the Systems Test and Quality Control team for compliance to company standards and any external quality requirements required.
- Validate standards and specifications based on customer expectations and technical scope of the product or system. Verify that validation testing is performed in accordance internal and regulatory requirements at the design, part, component, instrument and system levels.
- Actively lead internal and external audits/inspections; conduct risk assessments; develop plans for remediation and to mitigate risk.
- In compliance with Health Safety policies and procedures, must wear required Personal Protective equipment as described by company policy.
- Review reports and recommendations of the Safety Team including accident reporting and analysis; Collaborate with Safety Manager to improve process guidance or safety directives.
- Actively pursue up-to-date industry knowledge and implement benchmark and best-practice activities that maintain exceptionally high levels of product quality and compliance.
- Anticipate and implement innovative solutions that improve the company’s Quality System, save waste, reduce risk and consistently demonstrate best-in-class industry standards.
- Account for and manage compliance with federal, state, and local regulations that minimizes risk to employees and liability to the business.
- Collaborate with Executive team to determine strategic focus.identify and prevent problems by advance planning, and execute tactical activities aligned with the company’s strategic focus.
- Review manufacturing processes with Production Manager to adapt to infrastructure changes as the company grows.
- Collaborate with Production Manager and Chief Financial Officer to establish processes for inventory management and risk mitigation in Materials Control receiving processes.
- Interface with stakeholders, including customers, to ensure their expectations and requirements are met.
- Bachelor’s degree required. Advanced engineering or scientific degree strongly preferred. (An equivalent combination of experience and education may be considered.)
- Minimum of 5-7 years of quality and safety management experience.
- Experience working in environmental, biomedical, basic life sciences research and/or Quality Systems high-tech manufacturing environment is strongly preferred.
- Expected to bring a solid understanding of Regulations and Standards for ISO 9001:2015, ISO 13485:2016 and Environmental Health Safety (EHS) disciplines.
- Familiarity with business models that are dependent on cloud-platform databases. ERP Netsuite familiarity a plus.
- Track record in leadership, communication, and technical writing skills at all levels.
- Demonstrated ability to coach senior level staff to manage and develop high-performance quality systems aligned to company strategy.
- Experience in audit processes (both internal and external).
- Desire to work in and create a collaborative team setting.
- Ability to work and prioritize several projects at once while balancing multiple and overlapping timelines.
- Ability to assess workload and suggest prioritization to senior staff.
- Travel less than 10%.
About Sable Systems International
Trusted as the world leader in metabolic measurement, Sable Systems International has a 30+ year reputation for innovation, expertise, and scientific insight. We design and manufacture multi-platform high-resolution scientific instrumentation for the Life Sciences. Our applications range from Fly to Mouse to Human – and beyond.
Our best-selling products include multi-channel metabolic measurement systems for experimental animals such as mice and rats, with simultaneous measurement of other parameters such as food and water intake, body mass, position, activity, and environmental monitoring. Whether providing solutions for the measurement of a living process or an industrial one, model animals, or human personalized healthcare research, our unrelenting focus on quality and support is key to our success.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.