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Quality Assurance Specialist


. POSITION SUMMARY
Support and maintain core quality systems for compliance with FDA/GMP Regulations.
II. MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS
o Bachelor's Degree Required, Engineering Degree preferred.
o 1-3 years supervisory experience preferred.
o 5 or more years experience in a Quality Control, Quality Assurance Medical Device environment is required.
o Analytical, written/oral communication, PC (specifically Excel, Powerpoint and Sharepoint), and organizational skills will be essential for successful completion of duties.
o Ability to read blueprints/schematics and ability to write specifications desired.
o Experience with FDA and/or ISO Quality System Requirements required.
o Experience in an FDA and/or ISO regulated Environment or Medical Devices required.
o Experience with Six Sigma, Kaizen, 5S, Statistical Process Control or other improvement methodologies a plus.
o Experience with internal auditing and vendor evaluation/auditing required and RAB Certified Auditor preferred
o SAP knowledge a plus.
III. ESSENTIAL FUNCTIONS
A. PHYSICAL REQUIREMENTS
o Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
o This incumbent will work in a typical office environment. May need to spend significant amount of time in warehouse and/or repair service areas.
o Must be able to use phone and spend lengthy amount of time at computer creating/searching for information.
o Excellent communication skills, as this position may function as an audit host.

B. MENTAL REQUIREMENTS
o Must be able to manage multiple priorities.
o Position requires excellent organization skills.
o Position requires good judgment and decision-making skills.
o Position requires excellent attention to details.
C. DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)
o All employees are expected to be knowledgeable about and follow the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
o Initiate, investigate, and close customer complaints in a thorough and timely manner.
o Initiate, investigate and close QSAR's, CAR's and SCAR's in a thorough and timely manner.
o Ensure compliance with FDA/QSR Regulations.
o Maintain system for calibration of testing and measuring equipment.
o Answer technical and product questions and inquiries from customers, suppliers, and other XXX employees.
o Serve as a point person for problem solving and answering questions.
o Evaluate changes in products per organizational risk management practices to ensure effective, safe and compliant devices are released to the market in accordance with current state and federal standards.
D. ENVIRONMENT, HEALTH AND SAFETY:
o Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the Company's environmental and safety policies and procedures. Must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel.
o The incumbent in this position is responsible for knowledge of and adherence to policies and company procedures.
o Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.
o Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties.
o In addition, the position is responsible for acting on the information provided to him or her by subordinate employees by recording information and promptly pursuing resolution of any identified problems.
E. QUALITY
o The incumbent in this position is responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation.).
F. INTERPERSONAL AND COMMUNICATION SKILLS
o Must be able to maintain productive working relationships with co-workers.
o Must treat fellow employees with respect.
o Will interact with all levels of the organization locally and globally to communicate needs and relay information to XXX employees located at multiple locations. May also interact with external customers and suppliers. This will require effective written and oral communication skills.
o Must be able to adapt and demonstrate flexibility in dealing with changing priorities and work situations.
o Must demonstrate motivation and initiative.
IV. OTHER FUNCTIONS
A. OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)
o Material Review Board Member.
o Prepare information for Management Review Meetings.
o Participate or facilitate in Continuous Improvement events (Kaizen events).
o Participate on global QA/RA teams, as required.
B. OTHER PHYSICAL, MENTAL, INTERPERSONAL AND COMMUNICATION REQUIREMENTS
o None.



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