Job Description
As a Senior Quality Engineer, you will play a pivotal role in ensuring the commercial success of our products by supporting sustaining projects from a Design Assurance perspective.
You will be directly involved in maintaining our products throughout their full lifecycle and ensuring compliance with global standards.
In this capacity, you will support the introduction and implementation of product/process/materials changes to the manufacturing operation.
Assessing patient risk appropriately for these design changes is another critical aspect of this role.
You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg Engineering.
Key responsibilities include generating Design Verification protocols and participating in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.
Effective collaboration with Regulatory Affairs is essential to ensure information is clearly presented, minimizing Regulatory Agency questions.
Establishing strong working cross-functional relationships across the organization and with partners within a complex technical environment is crucial for success.
Additionally, you will maintain expert knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities.
Generating and approving change requests, leading investigation analysis, and timely completion of same are also key aspects of this role.
Collaboration with engineering and manufacturing functions to ensure quality standards are in place is vital.
Designing or specifying inspection and testing mechanisms and equipment, conducting quality assurance tests, and performing statistical analysis to assess the cost of and determine responsibility for products or materials that do not meet required standards and specifications are critical skills.
Ensuring corrective measures meet acceptable reliability standards and documentation is compliant with requirements is another key responsibility.
This role may involve specialization in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.
Collaborating with complaints teams for complex investigations is also an essential part of this role.
Familiarity with risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO, and ANSI/AAMI/ISO requirements is crucial.
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Required Skills and Qualifications
* Level 8 Engineering Degree
* 4+ years Experience in Quality/ Design Assurance/ R&D Engineering in the Medical Device Industry
* Experience with risk management, change management with product, process changing, material changing, design validation protocol, work cross-functional teams
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Benefits
Maintaining expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities.
Expertise in Design Verification protocols, quality assurance tests, and statistical analysis.
Strong working cross-functional relationships across the organization and with partners within a complex technical environment.
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Others
This is a challenging and rewarding opportunity for individuals who are passionate about ensuring the highest quality medical devices reach patients.
If you have a strong background in Quality Assurance and Design Assurance, combined with excellent communication and leadership skills, we encourage you to apply for this exciting role.