Quality Assurance Coordinator - United States
This position is responsible for the support and administration of core quality system elements to ensure compliance with FDA/QSR and ISO Requirements. Responsibilities include leading document control, Change Control, training and Document retention process as well as participating in process development/validation, quality system training, labeling inspections, supplier/internal/intercorporate quality audits and correspondence.
MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS:
- Associate Degree required. Bachelor's Degree preferred.
- 3+ years experience with Quality Systems in a medical device company desired.
- Distribution/logistics environment or equivalent work experience is a plus.
- Demonstrated knowledge of FDA/QSR and ISO Quality System Requirements.
- Computer proficiency, experience with common application programs – word, Excel, PowerPoint, database, and spreadsheets, required. Experience with SAP preferred.
- Strong written and verbal communication skills.
- Position requires good judgment and decision making skills.
- Position requires excellent attention to details.
- Requires physical movement of product with actions such as moving, reaching, grabbing, packing, lifting, stacking, pulling, and pushing. Position requires occasional heavy lifting, up to 40 lbs.
- Must be capable of making accept/reject decisions based on established procedure and criteria.
- Must be able to recognize and bring to supervisory attention situations which may impact quality but which are not covered in established procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Work to ensure processes are compliant with FDA/QSR and ISO Requirements.
- Author or supply direction in developing or revising procedures and work instructions to clearly and effectively document processes.
- Ensure compliance to established document control and record retention procedures.
- Maintain training records.
- Maintain labeling, manual, and insert reference library.
- Maintain complaint handling process.
- Coordinate and/or participate in process validation activities.
- Maintain system for calibration of testing and measuring equipment.
- Ensuring that all Regulatory and Quality requirements are followed as documented. This will require that the incumbent periodically monitor quality processes by attending meetings, reviewing work results, and completing spot audits.
- Ensuring that product(s) on complaints, quality/regulatory holds, and re-inspects are processed in a timely manner with proper documentation.
- Ensuring that KSEA Regulatory is notified of all Quality Holds issues immediately.
- Ensuring that all requests submitted to the Quality department are communicated and successfully resolved or transferred to the correct departments for resolution.
- Ability to travel to Inter-corporate or supplier audits. Attendance at other company meetings worldwide may be required. Travel estimated at 5-10 %.
- Participate and/or lead cross-functional improvement teams.
- Must be able to maintain productive and respectful working relationships with all employees.
- Strong written skills are required to proof read, edit, and write procedures
- Will interact with all levels of the organization to communicate needs and relay information to KARL STORZ employees located at multiple locations. May also interact with external customers and suppliers. This will require effective written and oral communication skills.
- Must be able to adapt and demonstrate flexibility in dealing with changing priorities and work situations.