Sr. Quality Systems Technician

Fresenius Medical Care•Knoxville, TN

About The Position

Conducts quality audits of products to ensure compliance with company standards and preserve product integrity. Consults with management to resolve quality, production, and efficiency problems. Under general supervision, follows established company policies and procedures and applies acquired job skills in accordance with QSR regulations, the ISO-9001 standard, and corporate and on-site policies and procedures. The role performs moderately difficult assignments requiring judgment to resolve issues or make recommendations, and may assist lower-level staff with complex support tasks as directed by the immediate supervisor. The employee works collaboratively across departments, escalates issues as necessary, assists with projects assigned by the direct supervisor, and performs other duties as assigned.

Requirements

  • High school diploma required.
  • Minimum 2–4 years of related experience.
  • General knowledge of GMP regulations.
  • Good organizational skills and ability to work with little supervision.
  • Computer skills with database, spreadsheet, and word-processing programs.
  • Strong oral and written communication skills.
  • Strong attention to detail.
  • Mathematical aptitude, including a good background in algebra and measurement skills.
  • Ability to routinely lift objects weighing up to 50 lbs as high as 5 ft above floor level.
  • Ability to walk and/or stand for considerable lengths of time and bend to floor level.

Nice To Haves

  • Associate’s degree preferred.

Responsibilities

  • Participate in quality audits to ensure compliance with regulations and internal policies and procedures.
  • Ensure records and activities are properly documented in accordance with regulations.
  • Follow company policies, guidelines, and Standard Operating Procedures (SOPs).
  • Maintain a teamwork approach and work effectively with other departments.
  • Assist lower-level staff with complex support tasks as directed by the immediate supervisor.
  • Escalate issues to the supervisor for resolution as necessary.
  • Review and comply with the Code of Business Conduct, applicable company policies and procedures, and local, state, and federal laws and regulations.
  • Assist with projects assigned by the direct supervisor and perform other duties as assigned.
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