· Support maintenance of testing equipment in laboratory including scheduling and/or performance of internal/external calibrations as required.
· Support and perform metrology measurement / inspection
· Administration of the CAQ (Computer Aided Quality) inspection system
· Coordinate calibration activities to provide support during process and equipment validation for QC laboratory.
· Support the maintenance of the Quality Irregularity Reports (QIRs) file and for periodic reporting in regards to QIRs.
· Perform special examinations in regard to QIRs, customer complaints, corrective and preventive actions if assigned.
· Preparation, editing and publishing of SOPs, TPs, and additional documents as related to Calibration activities.
· Issue Calibration stickers, Calibration Cards for all equipment
· Generate IQ, OQ, PQ protocols and reports as needed.
· Perform qualification activities for laboratory testing equipment as needed.
· Other duties as assigned
· Cooperation with external suppliers and other companies are required.
· Restriction of defective test equipment
· Administrative access on the CAQ (Computer Aided Quality) inspection system
· Communication and information exchange with affiliated Greiner facilities.
· Editing and distribution of SOPs, TPs, Forms and other applicable documents.
· Training of all employees regarding calibration procedures and use of equipment.
· Associate or Bachelor’s degree in Science, Engineering, Mathematics, or related field.
· Minimum of 3-5 years work experience in a medical device, pharmaceutical, or regulated environment. (ISO 9001, ISO 13485 experience is preferred).
· Must have experience with CAQ (Computer Aided Quality) inspection systems or calibration protocols.
· Must have experience working with manual, digital and electronic measuring equipment, including laboratory equipment.
· Must have experience with calibration of test equipment
· Must have Computer skills and MS office skills
· Must have knowledge of basic statistic and calculations
· Must have good communication and writing skills, including report writing.
· Proficient knowledge in applicable chemical calculations preferred
· Must pass pre-employment examination and qualification test.
· Must be able to stand and walk for up to 8 - 12 hours.
· Must be able to lift up to 50 lbs.
· Must have appropriate vision to perform detailed quality inspection as outlined in SOPs and TPs.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law.
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