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:

SSII, an US based medical devices company engaged in developing and manufacturing class II & III Surgical Robots is seeking a Head of Quality Control for its Gurgaon, India location. Join an organization with a passion for commercializing smart, effective and patient centric Robotics solutions. The Head of Quality is a key member of the site Leadership Team, and this role leads the SSII Quality and Quality System functions in India. This role will be a critical leader of a significant Quality function and will drive improvement activities including the maintenance of comprehensive quality metrics. Position will partner with the manufacturing and support teams to make recommendations, set goals, and implement solutions for process improvements. Another key component of this role will be leveraging the ability to effectively lead a team of approximately 30 people and facilitate the learning and development opportunities for QA/QC teams and the greater organization.

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