Senior Staff Design Quality Engineer

Cooper Surgicals; Gurugram District; On-site; INR 2,500,000 - 5,000,000; Full time

Job summary

Cooper Surgicals is seeking a Senior Staff Design Quality Engineer to provide technical leadership ensuring safe and effective Cooper products throughout development and manufacturing. You will apply design controls, risk management, verification/validation, and quality engineering techniques to meet industry standards and customer requirements.

You will guide teams across R&D, Operations, Regulatory, Supplier Quality, and Clinical to solve complex problems, mentor peers, and lead design reviews

Qualifications

• 10+ years of Quality Engineering experience in the medical device industry.
• Experience leading design changes and remediation initiatives.
• Knowledge of design controls, risk management, verification/validation, and QA processes.

Responsibilities

• Provide quality engineering leadership on product/process development teams.
• Mentor peers and cross-functional teams in Design Quality methodologies.
• Ensure design control requirements are met including verification, validation, risk management, and change control.
• Review and approve PPAPs and supplier quality qualifications.

Skills

Quality Engineering

Design Controls

Regulatory Knowledge

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering or related field

Job description

Job Summary

The Senior Staff Design Quality Engineer will provide technical leadership to ensure the successful development of Cooper products and ongoing operational support. This individual will be expected to apply his/her knowledge of design controls, risk management, verification and validation principles, and quality engineering techniques to ensure safe and effective products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.

The Senior Staff Design Quality Engineer provides expert guidance on scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position partners cross-functionally with R&D, Operations, Regulatory, Supplier Quality, and Clinical teams, and provides mentorship (including coaching, reviewing, training, delegating work) to peers, leads and less experienced DQEs, and cross-functional engineering teams.

Responsibilities

• Design Quality Leadership
  • Represent the Quality function on product/process development teams.
  • Mentor other discipline as needed in the Quality Engineering methodology.
  • Ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, design reviews, and design changes. May serve as independent reviewer during design reviews, or conduct DHF audits, as required.
  • Owner/Approver of one or more processes within the scope of Design Quality.
• Supplier Engagement
  • Manage supplier new tooling to ensure final components are qualified at the supplier and on time utilizing PPAP tool.
  • Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper s specifications.
  • Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team.
  • Review/Approval of PPAP. May serve as PPAP lead.
• CAPAs/Non conformances/HHE
  • Lead or Participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.
  • Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds.
  • Conducts or supports health risk assessments in support of the Health Hazard Evaluation, Reporting or Recall processes.
• Design
  • Participate in design reviews to evaluate designs and to help identify alternative design solutions.
  • Hands on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.
  • Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
  • Contributes to design input requirements from experience with previously reported problems, Cooper s products, competitive devices and/or other similar products.
  • Approves deviations and design changes, conducts impact assessments, and defines/approves implementation plans.

Experience

• 10+ years experience in Quality Engineering in the medical device industry with a Bachelor Degree, or 8+ years with a Masters Degree, experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
• Hands on experience in medical device product development in concept through commercialization, and/or leading design changes, improvements or remediation initiatives in sustaining operations. Knowledge in women s health a plus.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.