Position Summary:
Provide leadership in achieving the highest level of manufacturing quality of medical devices and quality system performance while ensuring compliance with all company policies and procedures.
Responsible for development, implementation, and continual improvement of quality systems and procedures supporting manufacturing operations, supplier management, documentation and records, training, quality management, and auditing.
Essential Job Functions:
Lead the Quality Management System supporting manufacturing process development and operations.
Ensure the integration of risk-based thinking throughout business processes to support decision-making.
Work with the management team to establish strategic goals and objectives as well as fostering organizational alignment.
Provide leadership for workforce education and development within Quality.
Develop, implement, communicate, and maintain quality planning supporting ISO 13485 quality system requirements and annual business goals and objectives.
Ensure individual performance and business process performance meets established goals and objectives.
Establish, follow, and improve company procedures as needed to maintain compliance and meet business goals and objectives.
Provide written and oral communication to help ensure an engaged and informed workforce and management team and keep them informed of results.
Maintain a cooperative and motivational attitude with co-workers.
Perform other tasks as requested by supervisor to meet business goals and objectives.
Adhere to all Company policies, rules, procedures and housekeeping standards.
Qualifications:
Education:
Requires a bachelor’s degree (Engineering, Science, or Business preferred).
A relevant post-graduate degree or qualification would be an advantage, but not essential.
Experience:
Minimum of 5 years of experience leading Quality Assurance / Quality Systems.
At least 5 years of progressive experience is needed in QA/QC management in a manufacturing environment, preferably in the medical device industry.
Knowledge of measurement systems and inspection process management.
Understanding of Mil, ISO, and other applicable standards.
Direct supervision of quality assurance employees in a manufacturing facility.
Other skills, abilities, or certifications:
ASQ certification or equivalent preferred (CMQ/OE, CSSBB, CQE, Lean Six Sigma).
Must be able to make solid decisions that effectively support the business and company policies.
Travel requirements are as needed.
Presentation skills and ability to train personnel in Quality and Regulatory Compliance.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Duties, responsibilities and activities may change at any time with or without notice.
Ki Mobility is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
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