The Quality Manager position develops, implements and manages quality control systems designed to ensure continuous production of virtual care equipment (consistent with established standards, customer specifications and production goals). The position supervises a team of quality control technicians.
- Ensuring a high level of internal and external customer service.
- Investigating and work with cross-functional team to correct customer issues and complaints relating to quality.
- Supervising team members engaged in inspection and testing activities to ensure high productivity and high technical integrity.
- Developing and analyzing statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products.
- Providing technical and statistical expertise to teams.
- Formulating, documenting and maintaining quality control standards and on-going quality control objectives.
- Coordinating objectives with production procedures in cooperation with Production Manager to maximize product reliability and minimize costs.
- Creating, documenting and implementing inspection criteria and procedures.
- Interpreting quality control philosophy to key personnel within company.
- Providing, and overseeing, inspection activity for product throughout production cycle.
- Applying total quality management tools and approaches to analytical and reporting processes.
- Interacting with vendors to ensure quality of all purchased parts.
- Creating and directing environmental test functions and applications.
- Maintaining active role on internal continuous improvement teams.
- Designing, developing and implementing quality control training programs.
- Performing internal audits.
- Addressing nonconformities from previous internal and external audits.
- Conducting a management review of the quality system.
- Following-up on and closing pending preventive and corrective action requests.
- Insuring that organizational systems and training is in place.
- Preparing organization for ISO 13485/9001 audit.
- Ensuring that documentation and design controls are appropriate for organization.
- Administering document control and configuration management system.
- Overseeing established calibration and testing program.
- Assisting the management team and provide QA support as necessary.
- Maintaining design history file.
- Excel expert, certification a plus
- Performance Management
- Technical Capacity
- Organizational Skills
- Teamwork Orientation
- Problem Solving/Analysis
- Communication Proficiency
- BS in engineering, biomedical sciences, a related technical field, or equivalent.
- At least 2 years of work experience in medical device quality assurance, should be combined with a demonstrated track-record of accomplishments as a quality assurance manager, and with satisfying customers in technology-driven, developing companies.
Job Type: Full-time
Salary: $50,000.00 to $70,000.00 /year
- medical device management: 2 years
- ISO 13485 and/or ISO 9001 certification
Required work authorization: