Quality Engineer Oxford Immunotec
THIS JOB HAS EXPIRED Overview:
Under limited supervision, monitors operations and develops and manages quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company?s North American operations.
Responsible for document control of the US SOPs and sales & marketing literature
Updates and maintains staff training files, facilitates training of all US staff on Quality System procedures, including document control, non-conformance, CAPA, handling complaints and customer feedback, and SOP training and re-training procedures, and Quality induction for new staff.
Ensures new staff adheres to their training schedule and that they provide regular updates for SOP & Training database
Conducts QC of raw materials for use in the laboratory
Ensures that equipment maintenance and servicing is performed according to specifications.
Support validation of laboratory procedures, collect and analyze data, and perform routine document review and special audits
Assists with the monitoring of compliance and ensuring the continuing effectiveness of the QMS according to ISO 13485:2012, ISO 9001:2008, CMDR and the QSR.
Works with UK and US staff to continuously improve the Quality Management System, streamlining documentation where possible with prior assessment of any associated risks
Assists the Director, Quality and Regulatory in handling customer feedback, including complaints in collaboration with US Director, Operations and Sales staff
Assists during internal and external quality audits
Communicates with the QMRA group on issues and activities
Assists with trouble shooting and investigations into issues with non-conforming product or work
Regular attendance and timeliness is essential
Bachelor?s degree and relevant technical/practical experience
? 5+ years Quality experience, preferably in laboratory or medical device environment
? Good working knowledge of MS programs
? Experienced in working to GLP and Quality Management principles
? Strong attention to detail and Quality commitment
? High standards of mathematical ability and writing
? Conscientious, thrives in high pressure work, and demonstrates strong initiative
PHYSICAL DEMANDS: The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Minimal travel required including international travel. Job requires employee to walk considerable distances in the facility during the course of his or her work.
||Memphis, TN |
THIS JOB HAS EXPIRED