Key member of the facility management team; will manage total quality program, policies, and initiatives. Responsible for identifying, analyzing, reporting, and developing improvements in productivity, quality and customer relationships, and customer service. Serve as an Synergy Health Process Expert.
RESPONSIBILITIES & DUTIES
· Perform final quality assurance review and release of all products manufactured, assembled, and/or distributed by the facility.
· Must be familiar with all processes, equipment and products utilized throughout the Synergy Health facility. Become the facility Process Expert.
· Monitor and ensure compliance with the quality assurance program established by the company to meet FDA and other applicable regulatory guidelines. Ensure that the requirements of 21 CFR 820 are implemented and maintained.
· Maintain product complaint system at facility level. Responsible for researching complaints, developing a corrective action plan in conjunction with facility management, implementing the plan and communicating corrective action responses to customers.
· Complete and maintain accurate records of all quality assurance programs established by the company and required by Synergy Health , the FDA or other regulatory body.
· Participate as part of the facility management team to identify document and investigate non-conformance issues at the facility, ensuring that appropriate corrective measures are implemented and monitored.
· Maintain the facility CAPA system and appropriate documentation.
· Interface with operations and engineering to assure Q. A. aspects are addressed with equipment changes/modifications.
· Conduct GMP, blood borne pathogen and other training programs as required.
· Performs periodic quality systems audits, and generates audit reports. Maintain the facility internal audit program.
· Generate reports and data analysis as required by SVP Process Engineering & QA and the RA Manager.
· Provide support to the Sales Team on Customer Issue Resolution and the presentation of Quality Metrics (BRs).
· Other duties as assigned.
Synergy Health is a service company which requires that you are always providing some level of service to either an internal or external customer. You are expected to make decisions that will in effect, positively impact and exceed the expectations of the customer base you serve. Accuracy, delivering on our commitments and the manner in which we execute each transaction must be done in such a manner that it positively spreads our organization’s reputation. Although we can not always choose the specific work assigned to us, we can however determine the attitude, behavior and personality we portray in completing our work.
Responsible for the supervision and management of the facility’s QA Technicians team. Guide and direct Quality Assurance Technicians, conduct employee performance reviews and recommend wage adjustments.
Indoor plant environment with occasional exposure to uneven temperatures, bio-hazardous materials and strong odorous chemicals and/or other elements.
Minimum of 2 years experience working in a Medical device or quality related field required. Experience working with device GMP preferred. Proficient with word processing and spreadsheet programs including some basic charting, graphing and data compilations.
B.S. degree preferred. Experience in Medical device, pharmaceutical, food/beverage Q. A. or other FDA regulated industries may be considered a substitute for education. Certified Quality Auditor and or Certified Quality Engineer preferred. High School diploma or GED required.
KNOWLEDGE, SKILLS, ABILITIES:
· Excellent verbal, written communication and mathematical skills required.
· Strong computer skills required, excellent working knowledge of MS Word, MS Excel. Experience with an instrument tracking system preferred. Experience with SRI’s current operating software preferred.
· Self-starter, ability to work independently when required. Ability to set priorities, be flexible, multi-task and meet deadlines. Ability to manage time and work under pressure with minimal supervision.
· Ability to interface with all levels of management.
· Ability to understand and interpret written requirements to assure adherence to documented procedures.
· Experience in problem solving and root cause analysis.
· Ability to interpret and implement device GMP’s.
· Lean Six Sigma experience preferred.
· Must be a team player.
5% to 10% travel potential to assist other SRI facilities and to attend relevant conferences and educational opportunities.
SYNERGY HEALTH IS AN EQUAL EMPLOYMENT OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER - M/F/V/D.
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