This position is located in Maryland.

This position reports to and is responsible for assisting the Quality Assurance Manager in directing and managing quality assurance and document control functions within the respective manufacturing facility. We are seeking a quality professional in a manageent role that understands FDA regulations, ISO 13485 certification and many other regional requirements such as MDD, CMDCAS, TGA and others. Other responsibilities include:

  1. Maintain and follow proper compliance and quality systems requirements.
  2. In the absence of an on-site Quality Assurance Manager, the Quality Assurance Chief will function as Management Representative Designee for respective manufacturing facility, with responsibilities as defined in the facility's Quality Manual.
  3. Based on site requirements, may have management responsibility for the Complaint Handling, Incoming, Internal Auditing, and Document/Change Control Systems.
  4. Based on site requirements, may have responsibility for writing of technical files for products, project reports, and procedures.
  5. Involvement with engineering projects for cost savings, reductions.
  6. Supervising of various levels of Quality Associates on projects and daily activities.
  7. Supervision and efficiency of document control center including review of internal and external audits.
  8. Maintain the quality system by assisting department in writing procedures, performing audits, assisting in findings ways to be more effective and efficient, etc.
  9. Designate for Quality Assurance Manager.
This position requires a four-year college degree in science, math or related field and 5 years experience working in quality. Strong background of statistics required. Basic knowledge of FDA regulations and ISO standards. Prior experience in manufacturing environment. Prior supervisory experience. Certifications from ASQC, CQE, etc., preferred. Strong writing skills. Communication skills both verbal and written. This position reports to the Quality Manager / Director.

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Quality Assurance Supervisor - Maryland

For more information, or to submit your resume, contact Suzanne Steele.