Head of Quality Control

Job Title:

Sudhir Srivastava Innovations Private Limited

Location: Udyog Vihar, Phase-III, Gurgaon, Haryana

Employment Type: Full Time

Relevant Experience: 7+ Year’s

Salary: As per the Industry Standard

Position Summary:

Responsibilities:

• Manage Quality Assurance, Quality Systems, Quality Control, Regulatory Affairs, Supplier Quality, Calibration, Complaint Handling, Document Control staff and PLM Administration.
• Train company employees on compliance with Quality System standards 21 CFR 820, ISO 13485 and ISO 14971.
• Develop and implement Quality System management strategies which integrate with company annual and long-term strategies.
• Ensure company is regulatory inspection ready at all times (USFDA, international regulatory bodies and customers).
• Direct investigations and implement CAPA/SCAR to resolve complaints and non-compliances.
• Have experience running Lean production, CpK, PPAP, FMEA and Gauge R & R capability studies
• Plan, coordinate and direct regulatory strategies for new products.
• Participate with the Management Team in developing and implementing relevant business and strategic plans.
• Have strong experience to control the quality on productions, Supplier Selection, and Supplier Management.
• Familiar with qualifying components, including inj. parts, metal parts, electronic parts, PCBA, etc.
• Acknowledge and respond to e-mails and tasks daily and accurately 12. Perform other assignments as requested.

Qualifications:

BS/MS in Life Science or Engineering.

Experience:

• 10+ years' experience Quality Systems/Regulatory Compliance submissions of Class I and Class II medical devices.
• 7+ years' experience at the Manager level
• Extensive knowledge of FDA Medical Device Regulation, ISO 13485, ISO 14971, FDA QSR and CE marking.
• Proven track record of building successful teams.
• Competence and confidence in leading teams and developing a cohesive team atmosphere.
• Proficient in Excel, Word, and MS Office/PC applications.

Note:

Thanks, HR Department