Summary: The Quality Assurance Specialist is responsible for coordinating designated quality initiatives to ensure compliance with FDA Current Good Manufacturing Practices, ISO 13485:206, and European Standards. This position supports the Quality Management System through maintenance of document control and the facilitation of investigation and closing of complaints, corrective and preventative action reports, supplier corrective action reports and product non-conformance reports. This individual performs incoming or production product inspections when needed and participates in audits of the facility conducted by notified bodies, the FDA, internal initiatives, and customers.
- Facilitates the investigation and closing of complaints.
- Facilitates and closes internal and supplier corrective action reports.
- Works with internal audit team to schedule and execute audits according to an approved audit schedule, reporting findings and ensuring corrective actions are appropriate and implemented.
- Distributes audit reports to management.
- Initiates nonconforming product processes.
- Assists in the management of recall and field correction activities by ensuring timelines are met and activities are properly documented.
- Maintains document control within the Quality Management System.
- Performs incoming and production product inspection, recording and uploading inspection results.
- Other related tasks as assigned.
- Customer Focus:Gives customers' internal/external needs priority and responds quickly to customer concerns. Demonstrates a desire to assist others, promotes positive behavior to internal/external customers. Eliminates systems/bureaucratic barriers to deliver exceptional service.
- Quality of Work: Verifies work to ensure accurate results, requiring minimal rework. Follows work instructions, procedures and company policies. Meets productivity standards, deadlines and project schedules; handles high volume workload.
- Team Orientation: Establishes and maintains effective relationships. Looks forward to interacting with co-workers, supports co-workers. Works within the team, recognizes and values others.
- Adaptability/Autonomy: Internally motivated; works well with little or no supervision. Maintains a productive schedule, timeline and goals. Maintains a positive attitude amidst change and pressure.
- Company Culture: Influences others to be excited and committed to a customer-centered work place. Supports the culture with daily actions of caring for and engaging with others creating camaraderie. Embraces the value of innovation, best practices and entrepreneurial ideas.
- Associate Degree
- 2 – 5 years of related experience including Quality Assurance and/or Quality Control
- Prior experience working in the Medical Device field or highly regulated industry, desired
- Basic math skills
- Knowledge of root cause analysis and problem solving methods, preferred
- Knowledge of Excel and basic Microsoft Office is required
- Professional writing skills and professional demeanor required
- Must be organized and detail oriented
- Internal Auditor Training, preferred
- Exerting up to 50lbs of force occasionally, and/or up to 20lbs of force frequently, and/or up to 10lbs of force constantly to move objects.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.