The following is intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
This position is responsible for carrying out Sr. level quality responsibilities according to ISO and FDA requirements and will be required to participate as the lead team member in establishing, maintaining and improving the quality system.
Duties and Responsibilities
The Sr. Quality Specialist will perform duties in support of the quality management system. Those duties include one or more of the following:
- Maintain and submit information for GUDID.
- Maintain information for training assignments in the Quality Management System (QMS), electronic and paper as applicable.
- Evaluate and audit suppliers as part of the supplier management process, and maintain supplier records in the QMS. Facilitate supplier investigations of quality issues.
- Initiate, evaluate, investigate and resolve customer feedback and complaints (CFCs). Document CFCs in the QMS. Submit reportable events to the respective regulatory agencies.
- Perform internal audits and maintain the schedule and internal audit records in the QMS.
- Coordinate and facilitate investigation activities, product impact, root cause analysis, corrections, corrective & preventive action as part of the CAPA process in the QMS.
- Assist in the preparation for and performance of regulatory inspections and external audits.
- Assist the QA Director with managing and improving the quality system. Facilitate Management Review.
- Train as a back up for any of the following duties: Document Control, and nonconformance management.
- Other duties as assigned
- Bachelor’s degree in a technical field preferred
- Experience in engineering/technical writing a plus
- Must have experience in the Medical Device industry
- Minimum of 5 years of Quality Assurance and/or Regulation Knowledge
- Regulation Knowledge can include: FDA 21 CFR Parts 801, 803 & 820, ISO 9001, ISO 13485, CMDR (Canada), MDD 93/42/EEC (EC).
- Highly organized individual with the ability to juggle multiple tasks at once
- Ability to read and comprehend regulations and technical writing
- Excellent communication and presentation skills
- Detail-oriented and self-starter
- This position works in an open office environment. While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit.
- The position may require up to 20% travel.
- Requires standing/walking/sitting 30 percent of the time. Requires the ability to travel on aircraft, car, bus, boat, or common transportation means.
- Requires use of hands and arms to operate computers, copy machines, and telephone.
Job Type: Full-time
Pay: $80,000.00 – $110,000.00 per year
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
- 8 hour shift
- Bachelor’s (Preferred)
- Medical Device Industry: 1 year (Preferred)
- Quality Assurance/Regulatory: 5 years (Preferred)
Work Location: One location