Quality Manager (CLIA, CAP, ISO 9001, ISO 17025 and QSR) Oxford Immunotec
# of Openings 1
Posted Date 6/19/2014
Job Location US-TN-Memphis
More information about this job:
Under limited supervision and with a solid understanding of science and technology, the Manager will be responsible for the day-to-day operation of the Memphis Quality Team and support the Quality & Regulatory Manager. The Manager will monitor, operate, develop and manage quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the Company?s Memphis site. The role is responsible for the ensuring the effectiveness of the QMS and monitoring compliance associated with CLIA, CAP, State regulations, ISO 9001, ISO 17025 and the QSR.
Recruit, develop, and mentor a high performing quality team
Responsible for the management of document control of the US SOPs and sales & marketing literature
Manage, update and maintain 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
Incoming Quality Checks:
Manages and conducts QC of raw materials and testing processes for the laboratory
Ensure that equipment maintenance and servicing is performed according to specifications
Ensure that all equipment is validated
Support validation of laboratory procedures, collect and analyze data, and perform routine document review and special audits
General QA responsibilities
Assist the quality management team with the monitoring of compliance and ensuring the continuing effectivenessof the QMS according to CLIA, CAP, State regulations, ISO 9001, ISO 17025 and the QSR
Manages the workload of the Memphis Quality Team.
Creates and provides quality metrics to the Quality and Regulatory Manager, Quality teams and other areas as required.
Works with UK and US staff to continuously improve the Quality Management System, streamlining documentation and processes where possible with prior communication and assessment of any associated risks.
Ensuring a consistent approach across the sites and where needed site relevant processes.
Communicates with the UK/US team on issues and activities.
Organises team meetings and interdepartmental meetings as required.
Project manages quality initiatives as required
Manage the logging and investigation of customer complaints and feedback to the sales team.
Completion of complaint metrics to identify trends.
Audits and Quality Oversight:
Manages the internal audit schedule and external quality audits such as CAP and CLIA.
Highly visible in the lab organising and conducting regular spot audits.
Non-conformance and CAPA:
Manages the logging, trouble shooting, investigation and progression of issues with non-conforming product, processes or work in a timely manner.
Produces regular metrics and identifies and acts on trends.
Follows all company safety policies & other safety precautions within work area
Regular attendance and timeliness is essential
Biological Sciences (or related) degree
5+ years Quality experience, preferably in laboratory or IVD/medical device environment with supervisory experience
Good working knowledge of MS Office, the Internet and databases
Experienced in working to GLP and a good knowledge of Quality Management principles
Strong attention to detail and Quality commitment
High standards of mathematics, writing ability and oral communication
Conscientious, thrives in high pressure work, and demonstrates strong initiative
Understanding of the scientific, biological and technical issues involved in developing diagnostic assays
Experience of the conduct of Internal and External Quality audits
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.
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