Key Accountabilities/Essential Functions:
1. To ensure Raw Material / Packing Material and finished goods testing in line with the SOPs.
2. To maintain device history records (DHR) & product release checklist for each lot.
3. To conduct inspections at in-process, in-coming and completes the final inspections.
4. To prepare technical documents like DMR & DHR.
5. To maintain microbial record in ISO class-7 & class-8 as per procedure.
6. Creating master documents to track calibration & latest version of documents and records.
7. To prepare control plan, FMEA & FAIR documents.
8. To prepare 8D and supplier CAPA reports.
9. Monitoring calibration activities.
10. Perform metrology activities & drawing reviews.
11. Coordinates investigation, root cause analysis & corrective action.
Technical/Functional Skill Sets:
1. Preferred skills in various metrology equipment, such as VMS, CMM programming, etc.
2. Product & process validation requirements & implementation.
3. Gauge R&R, CpK, PpK studies, IQ, OQ,PQ validation/qualification, MSA, run charts, etc.
4. Working knowledge of the ISO 13485 & ISO 9001standards.
5. FAIR inspection, DHR & control of documents.
Personal Qualities/Characteristics required for the position:
Good technical, analytical and trouble shooting skills.
Equipment Used:
1. VMS, CMM, Vernier caliper, micrometer, height gauge, etc.
2. Minitab software.#IND
Skills Required
- Perform raw material, packing material and finished goods testing per SOPs.
- Maintain Device History Records (DHR) and product release checklists for each lot.
- Conduct incoming, in-process and final inspections.
- Prepare technical documents including Device Master Record (DMR) and DHR.
- Maintain microbial records for ISO class-7 and class-8 environments.
- Create master documents to track calibration and document version control.
- Prepare control plans, FMEA and FAIR documents.
- Prepare 8D reports and manage supplier CAPA.
- Monitor and coordinate calibration activities.
- Perform metrology activities and engineering drawing reviews.
- Coordinate investigations, root cause analysis and corrective actions.
- Product and process validation implementation (IQ/OQ/PQ).
- Conduct Gauge R&R, CpK, PpK studies, MSA and run chart analysis.
- Working knowledge of ISO 13485 and ISO 9001 standards.
- Experience with FAIR inspection, DHR control of documents.
- Preferred: skills with metrology equipment such as VMS, CMM and CMM programming.
- Experience using Minitab statistical software.
What We Do
SMC Ltd. offers global solutions, contract manufacturing and molding services for the medical device, diagnostics, and pharmaceutical industries. Services include design, engineering, thermoplastic molding including insert, two-shot and micro, liquid silicone injection molding (LIM) and complete device assembly. Project integration, supply chain management, validation, packaging and labeling, and sterilization responsibility are systematically controlled. Facilities offer ISO 13485, quality systems, white room, class 7 and 8 clean rooms. SMC Group: Oval Medical Technologies, an SMC Ltd. company, is a medical device company developing in revolutionary autoinjector platforms. Oval’s unique approach allows for devices that are smaller, easier and safer to use than any other device currently available. Pharmaceutical partners can utilise Oval’s technology to deliver viscous formulations and sensitive biological drugs that would otherwise not be possible to deliver in current marketed injectable devices. Oval is able to tailor the technology for specific patient populations producing devices that are truly patient centric. www.ovalmedical.com
