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.
Experience
5 to 12 years of experience within a regulated industry, medical/pharma experience preferred
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, executes and recommends modifications to documents where appropriate.
Reviews Document changes to verify accuracy and completeness, including Technical Files, clinical data, risk management files, and traceability reports.
Confirms objective evidence for product development efforts is present and filed within the DHF
Performs audits of data integrity among Design History Files
Creates draft risk management documentation for medical device products
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
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 workplace 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
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
Bachelor's 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.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.