Must Have Skills: Must Have Skills: Must have experience in medical DEVICES- Spinal, Foot, Ankle
Education: Bachelor's Degree
Education: Bachelor's Degree
Description:
Description:
Directs and coordinates activities and operations of quality assurance department and staff. Providing the leadership, mission and vision for Quality organization.
- Developing, implementing and maintaining Quality Assurance and Regulatory Affairs systems and activities within FDA and international regulatory guidelines.
- May act as appointed Management Representative.
- Coordinates with other managers and associates to identify critical success factors, develop measurement systems, and implement continuous process improvement methodologies.
- Designs, develops, and implements comprehensive quality assurance programs.
- Maintains, enforces, and measures quality assurance processes.
- Defines and manages an end-to-end test environment including but not limited to selection of tools, methods, and process.
- Responsible for product performance and continuous improvement efforts.
- Reviews and evaluates services to correct deficiencies and formulate improvements.
- Assures on-time delivery of new projects; ensures product quality, performance, and conformity with company established specifications.
- Assists with the planning and implementation of new programs, services, and projects; monitors progress and evaluates results; recommends changes or other action as appropriate.
- Maintains and manages department budget.
- Reviews, analyzes, and implements technological changes to enhance performance and customer requirements.
- Hires, trains, supervises, motivates, and develops quality assurance staff; manages schedules and workflow.
- Maintains the Quality System: CAPA and Internal Audits.
- Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations.
- Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance.
- Coordinates Outside Inspection of the Quality System: FDA and Notified Body auditors.
- Coordinates Outside Inspection of the Quality System: FDA and Notified Body auditors.
- Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
- Manages directly and/or through subordinate supervisors the activities of the Regulatory Affairs & Quality Assurance department.
- Develops and conducts staff training.
- Conducts performance/merit reviews.
- Coordinates priorities with associated managers.
Qualifications/Work Experience - Bachelor - - -’s degree (B.S.) or equivalent in related field.
- 6-10 years related experience or equivalent.
- Must have strong experience working directly with the FDA
- Must have exceptional team building skills and a passion for developing others
- Must have strong relationship skills and be able to work well with diverse groups of people
SUMMARY
I enjoy enabling business growth and transformation by identifying solutions through creative talent acquisition strategies and recruiting process improvement. My experience in the Navy as a
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