Job details

Job title:

Sr. Quality Engineer

Company:

SMC Ltd.

About Us:

SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

Academic Qualifications-Degree (BE or B. Tech or B. Pharm or M. Pharm)

Experience (Years)-7 years & above

Industries in which candidate has worked-Medical device, Pharma & Healthcare industry

Position Scope & Purpose-Working knowledge of various metrology devices like Vision Measurement System (VMS), Co-ordinate Measuring Machine (CMM), Vernier Caliper, Micrometer, Comparator, Height Gauge, etc.

Key Accountabilities/Essential Functions

- Develop and establish quality procedures & shift schedules for inspectors for testing of products in all stages of manufacturing.
- Review product drawings, classify all the probable nonconformities into various risk categories & define a control plan (inspection & lab test methods & sampling frequency, sample size & AQL) for all.
- Interact with engineering function on FMEA & inspect & review engineering releases, adhering to strict guidelines on quality risk management methods.
- Perform process audits, product audits & internal quality audits and report the findings.
- Maintain a CAPA log record, follow up on open CAPAs, and update.
- Train quality engineers, inspectors & operators on updated work instructions & quality control methods and guide them on measurement (metrology) methods.




- Work with the production team to implement testing criteria or assembly methods developed
- Organize incoming inspection of raw materials & bought-out parts, an in-process inspection of items & final inspections of finished products as per defined frequencies. Conduct supplier audits, and monitor supplier quality performance & corrective actions if any.
- Monitor cleanroom conditions by organizing external testing as per AHU re-qualification procedures.
- Maintain the list of monitoring and measuring devices, schedule & organize periodical calibration.
- Facilitate successful qualification/validation of processes in product development (IQ, OQ, & PQ), record the results & document them as applicable & as defined by the customer for all the phases.
- Perform gauge R&R;, process capability studies, etc. to meet quality deliverables.
- Identify & retain customer-approved samples, control samples & defect limit samples if any.
- Oversee cleanroom activities by daily rounds to ensure that the production & assembly processes adhere to the planned controls and critical process parameters.
- Compile all the documents into respective Device Master Records.
- Review and maintain the inspection logs production and quality records daily.
- Review the Device History Files (DHF - for defect incidences, if any) & make certificates of analysis /or conformity to recommend product releases.




- Organize to collect samples, check for visual (physical) defects, e.g. color, texture & strength & locate imperfections; measure control dimensions.
- Periodically monitor, review & update the inspection & testing procedures, improvement is required.
- Find the root causes of defects & develop creative solutions using problem-solving techniques.
- Provide timely feedback to engineering & production regarding product non-conformity & ensure timely disposition of non-conforming products and closure of NCMRs.
- Ensure that changes & deviations, if any, are documented and are approved prior to implementation.
- Perform the tasks as may be required from time to time as assigned by the management.
- Technical/Functional Skill Sets
- Strong attention to detail & documentation & the ability to provide professional & technical support.
- Valuable statistical analysis, time management & training skills.
- Strong Microsoft software skills (Word, Excel, Outlook & Minitab).
- Six sigma principles - green belt training & basic knowledge in SPC & SQC.
- Trained & certified internal quality auditor.
- Awareness of ISO 13485 & 21 CFR 820 standards.
- Medical devices - risk assessment & risk control techniques.
- CAPA Management.
- Good understanding of GMP requirements, guidelines & regulations.

#IND

#LI-EH1

Job Types: Full-time, Permanent

Pay: ₹294,391.88 - ₹1,000,000.00 per year

Benefits:

- Food provided
- Health insurance
- Life insurance
- Provident Fund

Schedule:

- Day shift
- Morning shift
- Night shift
- Rotational shift

Supplemental Pay:

- Yearly bonus

Experience:

- Quality assurance: 7 years (Preferred)

Work Location: In person

📌 Sr. Quality Executive (India)
🏢 SMC
📍 India