Director of Quality Assurance
Location
Nevada | United States
Job description
Hamilton Medical was founded with a vision: To develop intelligent ventilation solutions that make life safer for patients in critical care and easier for the people who care for them. Today, Hamilton Medical is a leading manufacturer of critical care ventilation solutions for a wide variety of patient populations, applications, and environments.
The Director of Quality Assurance is responsible for contributing to the growth and sustainability of Hamilton Medical, Inc. by assuring that quality levels of the Company's products conform to Hamilton Medical, regulatory, and customer standards at optimum cost while ensuring compliance with all regulatory requirements.
RESPONSIBILIITES
- Provide value-added and solution-based support by implementing policies and procedures to maintain and improve manufacturing practices toward quality in a Medical Device and Scientific Equipment environment, ensuring that product meets corporate, regulatory, and customer standards.
- Maintain a system-wide Quality Assurance Program compliant with FDA regulations and other relevant global standards, including ISO 13485.
- Complete and issue European Declarations of Conformity, including declarations for Ventilators.
- Work with Product Management to supply complete documentation for customer FDA submissions.
- Provide company-wide Quality System training to ensure a quality-oriented labor force.
- Implement compliance programs for OSHA, EPA, local Fire Department, and other Safety/Environmental agencies.
- Conduct product recalls, including customer notifications and any required FDA, Health Canada, or other global agency communications, as necessary.
- Conduct system-wide audits (system, process, safety/environmental, and stock audits) of all processes and methods used in the design, promotion, manufacture, packaging, storage, and distribution of product to assure that all quality standards are being met.
- Work with department heads on planning and implementation of resolutions and risk mitigations.
- Prepare and distribute reports on quality metrics to management and suggest appropriate improvements and corrective actions.
- Maintain close liaison activity and cooperation with U.S. and Swiss Hamilton Medical teams such as: Product Management, R&D, Operations, and Marketing.
- Staff and maintain a well-trained work force team at levels appropriate in accordance with established policies and procedures. Develop management and technical skills to preclude technical obsolescence.
- Contribute to cost reduction program by implementing cost savings based on analysis of defect history and customer service reports, and evaluations of product specs.
- Prepare and administer approved departmental operating budgets, long range goals, and ensure that it is complied with.
- Personally control and handle government, customer, and other quality related audits, including reporting and advising corrective action.
- Act as Management Representative for the Quality System (pursuant to FDA's 21 CFR 820 and ISO 13485).
- Work closely with Swiss parent company, Hamilton Medical, AG, to coordinate and harmonize quality and regulatory systems and objectives.
- Work with product management and outside legal counsel on customer-related legal affairs.
- Manage/oversee a Principal Regulatory Affairs and Quality position.
- Advice on and coordinate the approval of high-level registration of medical devices.
- Other duties as assigned.
MANAGEMENT REPRESENTATIVE RESPONSIBILITIES
Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes:
- Ensure that processes needed for the quality management system are documented.
- Report to top management on the effectiveness of the quality management system and any need for improvements.
- Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
The Management Representative currently appointed is the Director of Quality and Regulatory.
- Expert knowledge of Medical Device Regulatory Requirements (U.S. FDA, EU, and other applicable global agencies), Quality System requirements, and of physical measurements and statistical methods.
- Strong and credible reputation with peers, with the FDA and other regulatory agencies, with customers, and with registrars.
- Track record of managing and completing projects and tasks on time and within budget.
- Accountable for the success or failure of the total quality assurance operation and for the proper expenditure and management of annual budget.
- Position requires exerting up to 10 pounds of force occasionally and/or negligible amount of force to lift, carry, push, pull, or otherwise move objects.
- B.S. or M.S. in Physical Science, Engineering, or related field required .
- Minimum of ten years industrial quality assurance experience required .
- Minimum of three years management at department level required .
- Anticipated salary range is $131,000 - $243,000/year.
- Diverse portfolio of exciting and innovative design projects.
- Tremendous opportunities for professional growth.
- Commitment to sustainable design.
- Competitive compensation.
- Excellent benefit package includes medical, dental, vision insurance, paid vacation time, paid sick time, disability insurance, 401k, tuition reimbursement and more.
- Solid stable company.
- Must pass drug and background screens.
- May be required to wear Personal Protective Equipment (provided by employer).
USD $187,200.00/Yr.
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