Senior Quality Engineer

ACCPRO; Burlington; On-site; CAD 80,000 - 201,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Senior Quality Engineer for a 12-month contract. The role involves supporting commercial projects, ensuring compliance with global standards, and generating verification protocols. Ideal candidates will have strong experience in quality assurance, regulatory compliance, and project management.

Qualifications

• Experience in medical device quality assurance.
• Knowledge of FDA and ISO standards.
• Strong analytical and problem-solving skills.

Responsibilities

• Support sustaining commercial projects from a Design Assurance perspective.
• Generate Design Verification protocols for regulatory submissions.
• Collaborate with engineering and manufacturing functions to ensure quality standards.

Skills

Design Assurance

Quality Assurance

Regulatory Compliance

Statistical Analysis

Risk Management

Education

Bachelor's Degree in Engineering or related field

Job description

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Senior Quality Engineer

Location : Galway

Industry : Medical Device

Duration : 12 Months Contract

Start : ASAP

• Support sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards.
• Support the introduction / implementation of product / process / materials changes to the manufacturing operation. You will assess the patient risk appropriately for these design changes. You will provide QA technical direction / input to qualification and validation activities in conjunction with R&D and Mfg. Engineering.
• Responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.
• Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
• Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.
• As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities. You will generate and approve change requests. Lead investigation analysis and timely completion of same.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and / or research and development as they apply to product or process quality.
• Collaborate with complaints team for complex investigations.
• Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI / AAMI / ISO 14971 : 2019, and ANSI / AAMI / ISO 13485 : 2016 requirements.

Please contact Alan on [e-mail] for further information

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Contract

Job function

Job function

Quality Assurance, Engineering, and Production

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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