Quality Technician II in Coventry, RI at APEX Systems

Date Posted: 10/21/2019

Job Snapshot

Job Description

Job #:  1018619


QA Technician
Coventry, RI
Shift: 8:30am – 5:00pm, Mon-Fri
Duration: 6 months (busy period)
Purpose Statement
To perform quality assurance activities to assure all processing requirements are met prior to QA approval for all products processed. Assists the Quality Assurance Manager to assure that requirements are met according to documented and communicated policies and procedures.
Key Responsibilities
  • Perform the review and approval of all sterilization batch records to assure that all processing parameters have been met according to Specifications.
  • Assist in the maintenance of policies and procedures as they pertain to sterilization and batch approval.
  • Perform the review and approval of operating logs and charts (preconditioning, aeration, SCBI incubation, BI storage & shipping and receiving). Assist with the review and maintenance of calibration records to assure calibration is performed per documented procedures.
  • Identify quality issues and interface with plant representatives. Executes the disposition of nonconforming loads through approved nonconformance reports.
  • Identify best quality practices and areas for improvement and participate in continual improvement projects across facility.
  • Contributes to maintaining a safe and clean working environment by performing routine area housekeeping and reporting any unsafe conditions.
  • Initiate non-conforming reports and corrective action requests (if applicable) for all cycle non-conformances.
  • Perform other duties as required. Perform tasks not listed in this job description per guidance from Quality Assurance Manager or Corporate management.

Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Job Scope and Leveling Guidelines
Knowledge
Solid knowledge of the job. Applies broad knowledge of business concepts, procedures and practices and a general understanding of department fundamentals.
Cognitive Skills
Performs routine and some non-routine assignments using standard methods and sequences. Makes adjustments, modifications, and replacements to set processes as directed. Assignments require limited judgment in troubleshooting proven processes.
 
Requirements:
  • High School Diploma or equivalent
  • 1-3 years of relevant work experience in regulated industries; Medical Device experience preferred
  • Ability to work on weekends on rotating schedule if required
  • Must be able to differentiate colors to perform testing
  • Ability to read, interpret and conform to batch records to Quality and Safety requirements with keen attention to details and accuracy
  • Ability to communicate effectively (in written or verbal format) with both internal and external customers
  • A team player mentality, which includes being self-motivated, accepting responsibility for one’s work and productivity, completing assigned action items in a timely manner, and participating as a team member of the department with a proactive attitude

 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.