Senior Engineer- Design Quality

Senior Design Quality Engineer

JOB SUMMARY

This position represents the quality organization as an integral team member on development projects for medical devices. The Design Quality Engineer (QE) ensures compliance to QMS and design control process and procedures and ensure maintenance of Quality Records for the design and development of the products.  They ensure adherence to customer and regulatory requirements are demonstrated and help to ensure successful transfer of the design to manufacturing.

This individual performs routine functions which require application of standard techniques, procedures, and criteria in carrying out a sequence of related engineering tasks.  Using prescribed methods, performs specific and limited portions of a broader assignment of an experienced Engineer.  Duties are assigned to provide experience and familiarization with Design Control regulations and requirements, engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

• Supports product design changes and new product development projects, working closely with the development team
• Ensures compliance to QMS and design control processes and procedures
• Reviews and approves documentation that supports product releases
• Interprets, execute and recommends modifications to documents where appropriate.
• Reviews Document changes to verify accuracy and completeness, including Technical Files, clinical data and traceability reports.
• Good hands-on experience with the Risk Management Documentation (ISO 14971)
• Confirms objective evidence for product development efforts is present and filed within the DHF
• Performs audits of data integrity among Design History Files
• Performs DHF Audits prior to and after Design Transfer
• Analyses data for post market monitoring and risk management
• Interprets, executes, and recommends modifications to documents where appropriate
• Implements and understands ISO, EuMDR and regional regulatory requirements as necessary.
• Preferred experience on Medical Equipment or Disposable

OTHER DUTIES AND RESPONSIBILITIES

• Work assignments may require additional development and a maturing of in-depth engineering skill(s) or breadth to eventually include
  • Reviews and approves new or revisions of protocols/operating instructions specific to the project
  • Reviews and approves testing, project experiments and analysis of data along with reports
  • Reviews and approves design verification and design validation protocols and reports

• work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• Additional projects assigned as needed

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelors degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Experience

• Minimum 5 years of experience within a regulated industry, medical/pharma experience preferred

Skills

• Write and speak fluent English required
• Shows initiative as a self-starter to complete tasks as assigned required
• Planning skills to prioritize and execute multiple projects required
• Detail oriented required
• Willing to seek guidance while carrying out instructions furnished in written or verbal form and takes task approach to ensure assignments are accomplished according the guidelines and schedules required
• Demonstrated desire to continually learn and keep up with changing technology
• Knowledge of protocols, and statistical tools, preferred
• Possess ability to apply fundamental techniques and latest principles of technology to develop and enhance projects
• Ability to comprehend in depth knowledge of product design and process development specific to the project
• Able to work cooperatively and effectively in a team environment to achieve common goals and results
• Knowledge and use of relevant PC software applications and skills to use them effectively
• Knowledge of ISO standards desired
• Demonstrated ability to communicate effectively both verbally and in writing 

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

As per Indian regulation.

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