Contacts: This position interacts with all levels of employees & suppliers (& internal customers) appropriately.
Position Scope & Purpose:
Maintains quality standards by sampling, inspecting & labeling (physical & mechanical checks & tests) of incoming materials & components as used in the manufacture of molded parts, sub-assemblies & finished medical devices as per control plans, SOPs & WIs. Assures accuracy & correctness of data & maintains inspection results in Device History Records.
Key Accountabilities/Essential Functions:
1. Performs receiving inspections (visual & dimensional) on incoming raw materials, packing materials & components purchased, as per defined specifications.
2. Performs monitoring of key process inputs & process variables & communicates the shop-floor process adjustments, as may be required, to the appropriate production personnel & work with them.
3. Performs in-process inspections (visual & dimensional) on components being produced &/or packed in the prescribed packing materials, as per defined specifications.
4. Rejects nonconforming materials & components by segregating, labeling & quarantining the lots. Communicates & reports the nonconformity to supervisor.
5. Participates in new product developments & process validation per protocols. Reads & perform first article inspection (FAIR) as per drawings using inspection guide sheets & standard & custom gages.
6. Performs inspections on finished products before they are packed in cartons, stored & palletized for shipping, as per defined specifications &/or as per customer requirements.
7. Monitor & maintain the critical measuring equipment & instrumentation to ensure proper operation.
8. Coordinate periodical calibration of all measuring & monitoring devices & fixtures.
9. Supports investigating root cause analysis & corrective & preventive actions for customer complaints.
10. Control of QMS documents & retention of records.
11. Documents inspection results by completing reports & logs; inputting data into quality database.
12. Maintains safe & healthy work environment (cleanroom) by following standards & procedures.
13. Assist in the writing & updating inspection checklists & reports.
14. Evaluate problems & make initial recommendations for possible corrective action to supervise.
Technical/Functional Skill Sets:
1. Quality inspection of plastics injection molded & assembled medical devices.
2. Quality Management Systems (QMS) Requirements (QA / QC) – preferably ISO 13485.
3. Good mechanical aptitude, arithmetic, analytical quality engineering & technical process engineering experience in trouble shooting & process improvement.
4. General proficiency in computer applications like Minitab, MS Word, Excel, PowerPoint, Outlook, etc.
Personal Qualities/Characteristics required for the position:
1. While performing the duties of this job, the employee is regularly required to stand; walk, & sit for extended periods of time. Should be willing to work in night shifts & weekends.
The above statements are intended to describe the general nature and level of work being performed by the incumbent(s) of this job. They are not intended to be an exhaustive list of all responsibilities and activities required for the position.
This job description will be reviewed periodically as duties and responsibilities change with business necessity. Essential and other job functions are subject to modification.
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