Medical Device Quality Inspector

Primary Talent Partners

Medina, NY

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JOB DETAILS

SALARY

$26.75 Per Hour

SKILLS

Biology, Biotech and Pharmaceutical, Current Good Manufacturing Practice (cGMP), Documentation, ERP (Enterprise Resource Planning), Electronics Manufacturing, FDA (Food and Drug Administration), FDA Requirements, Healthcare Quality, High School Diploma, Infusion Pumps, Java IDE (Integrated Development Environments), Manufacturing Execution Systems (MES), Medical Equipment, Process Control Engineering, Pumps, Quality Assurance, Quality Control, Record Keeping, Testing, Wireless Communications

LOCATION

Medina, NY

POSTED

11 days ago

Primary Talent Partners has a 5 month contract opening for a Medical Device QA Inspector to join a multinational medical device and life sciences company for an onsite position operating out of Medina, NY.

Pay: $26.75/hr
Contract: 5 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship
Schedule: Monday through Thursday: 5:30am - 4:00pm | OT as needed on Friday

Responsibilities:

Perform the inspection of Device History Record (DHR) documentation for infusion pumps and wireless battery modules either on paper or in the electronic Manufacturing Execution System Camstar to ensure test procedures have been completed and release specifications are within specifications for final acceptance and release.
Perform inspection of the pump or wireless battery module to ensure all visual aspects, including approved labels, are met prior to release of the pump or wireless battery module.
Approves the release of the pump and wireless battery modules in the appropriate ERP system, as applicable (JDE B4ONE, JDE GME)
Ensures there are no open nonconformances associated with the pump or wireless battery modules in the approved nonconformance tracking system.
Reviews the device history log within a pump to ensure final testing has been completed in accordance to the applicable procedure.
Accurately record all failing observations using the rework form in Camstar or the nonconformance system as applicable.
Dispositions the rework activities of nonconformances and completes the electronic approval and closure process for any non-conformances with the device in the approved electronic system.
Ensure process control and maintenance procedures are being followed.
Recognize out of compliance/out of tolerance situations and take appropriate action.
Inspect Service Parts and approve release of the parts.
Assist with identification and containment of nonconforming product on the floor for internal investigations and holds.
Perform other duties as assigned.

Education and Experience Required:

High School diploma or GED.
Preferred experience in a pharmaceutical or Biotech industry helpful.
Must be familiar with cGMP and FDA requirements.

Qualifications include experience with:

Measurement equipment.
cGMP documentation and FDA
Basic ESD requirements
Computer based programs
Data entry and spreadsheet applications.
Perform repetitive motions with hands/fingers.
May be required to work flexible hours and overtime on short notice.
Ability to visually inspect and identify particulate/foreign matter and distinguish between colors as required by FDA Current Good Manufacturing Practices.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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About the Company

Primary Talent Partners

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