Design Quality Engineer
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Responsibilities
The Engineer ensures quality assurance protocols throughout the product design process, from concept to commercialization. Responsibilities include compliance with safety, quality, and regulatory standards for worldwide distribution, as well as developing methods for inspecting and evaluating production processes and products. This role involves working with an existing Quality Engineering team to achieve the following:
Ensure design and development processes are followed and documented to maintain quality at all stages.
Ensure compliance with regulatory procedures throughout the product life cycle.
Support internal and external audits.
Collaborate with other teams and stakeholders.
Collaborate with design and engineering teams to ensure product realization processes are applied and compliant.
Review design and development documentation for adequacy and consistency with global processes.
Support, evaluate, and monitor verification and validation processes.
Participate in the design and development phase to support risk management and implement required controls.
Define and ensure the collection and analysis of statistical data.
Assist engineering teams with root cause analysis and corrective actions.
Support New Product Introduction/Design Transfer activities to ensure smooth transition from R&D to manufacturing.
Generate internal quality documentation (quality plans, SOPs, inspection procedures) and ensure compliance with QA, FDA, and ISO standards.
Review and approve product and Quality System changes with Engineering and Manufacturing.
Provide engineering support to resolve issues impacting production fulfilment.
Participate in Quality Review Boards and investigate customer/internal complaints.
Ensure effective product acceptance based on DMR.
Assist in implementing QA plans, process controls, and CAPA systems.
Evaluate manufacturing processes by designing and conducting research programs.
Lead and participate in process validation and risk management activities.
Education And Experience
B.S. degree (ME or EE ) and 5-8 years of related experience in the medical device industry OR M.S. Degree with 4+ years of related experience.
: ASQ Certified Quality Engineer or Certified Reliability Engineer.
The Engineer ensures quality assurance protocols throughout the product design process, from concept to commercialization. Responsibilities include compliance with safety, quality, and regulatory standards for worldwide distribution, as well as developing methods for inspecting and evaluating production processes and products. This role involves working with an existing Quality Engineering team to achieve the following:
Ensure design and development processes are followed and documented to maintain quality at all stages.
Ensure compliance with regulatory procedures throughout the product life cycle.
Support internal and external audits.
Collaborate with other teams and stakeholders.
Collaborate with design and engineering teams to ensure product realization processes are applied and compliant.
Review design and development documentation for adequacy and consistency with global processes.
Support, evaluate, and monitor verification and validation processes.
Participate in the design and development phase to support risk management and implement required controls.
Define and ensure the collection and analysis of statistical data.
Assist engineering teams with root cause analysis and corrective actions.
Support New Product Introduction/Design Transfer activities to ensure smooth transition from R&D to manufacturing.
Generate internal quality documentation (quality plans, SOPs, inspection procedures) and ensure compliance with QA, FDA, and ISO standards.
Review and approve product and Quality System changes with Engineering and Manufacturing.
Provide engineering support to resolve issues impacting production fulfilment.
Participate in Quality Review Boards and investigate customer/internal complaints.
Ensure effective product acceptance based on DMR.
Assist in implementing QA plans, process controls, and CAPA systems.
Evaluate manufacturing processes by designing and conducting research programs.
Lead and participate in process validation and risk management activities.
Education And Experience
B.S. degree (ME or EE ) and 5-8 years of related experience in the medical device industry OR M.S. Degree with 4+ years of related experience.
: ASQ Certified Quality Engineer or Certified Reliability Engineer.
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