Oxford Immunotec, Inc.

Quality Assurance Supervisor

US-MA-Norwood
2 months ago
ID
2017-1767
# of Openings
1
Department
Quality & Regulatory

Overview

Under limited supervision and with a solid understanding of science and technology, the supervisor will be responsible for the day to day operation of the Norwood Quality Assurance Team and support the Sr. Manager of Quality. The supervisor will monitor, assist in development of and manage quality improvement initiatives to ensure that systems are safe, effective, appropriate, compliant, current, and adhered to by staff for the company’s Norwood Site. The role is responsible for assisting the Sr. Manager in ensuring the effectiveness of the QMS and monitoring compliance associated with CLIA, CAP, HIPAA, State regulations, and the FDA Quality System Regulations.

Responsibilities

  • Document Control:
    • Responsible for the supervision of document control of the US SOPs and sales & marketing materials
  • Training:
    • Responsible for overseeing the management of new employee induction and maintenance of staff training and competency files. 
    • Facilitates training of all US staff on Quality System procedures, including document control, non-conformances, CAPAs, handling complaints and customer feedback, and training and competency.
    • Ensures new staff adhere to their training schedule and that they provide regular updates for tracking purposes.
  • Validation:
    • Ensure that all Equipment, Test Methods and Systems are properly validated and maintained.
    • Perform or delegate where possible the Quality Review of all validation documentation to ensure compliance with regulatory requirements.
  • Non-conformance and CAPA:
    • Supervise the initiation, investigation and progression to closure of non-conformances, deviations, and CAPAs in a timely manner.
  • Complaints:
    • Supervise the investigation of customer complaints and negative feedback 
    • Completion of complaint metrics to identify trends.
  • Process Change and Improvement:
    • Support implementation of new procedures, collect and analyze data, and perform routine document review and audits as requested.
    • Assist in the implementation of the Electronic Quality Management System.
    • Assist in integration efforts for acquisitions and ensure a consistent approach across the sites wherever possible.
  • General QA responsibilities
    • Produce regular metrics and identify and act on trends related to areas of responsibility.
    • Assist the quality management team with the monitoring of compliance and ensuring the continuing effectiveness of the QMS according to CLIA, CAP, HIPAA, State regulations, and the FDA QSR.
    • Manage the workload and career development of direct reports.
    • Communicate with the global quality team on issues and activities.
    • Organize and facilitate employee, team, and interdepartmental meetings as required.
    • Project manage quality initiatives as required
  • Follows all company safety policies & other safety precautions within work area
  • Regular attendance and timeliness is essential 

Qualifications

  • Biological Sciences (or related) degree 
  • 2+ years Quality experience (preferred), preferably in laboratory or IVD/medical device environment with supervisory experience
  • Good working knowledge of MS programs, databases, and electronic quality management systems 
  • Experienced in working to GXP requirements and a good knowledge of Quality Management principles
  • Strong attention to detail and Quality commitment
  • Highly effective written 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

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.

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