Quality Assurance Engineer - Medical Devices

Engineer, Quality Assurance

Work Flexibility: Hybrid or Onsite

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. The job requires attention to detail in making evaluative judgements based on the analysis of information. This position involves in-depth knowledge of EUMDR requirements, collaboration with cross-functional teams, and proactive management of regulatory compliance throughout the product life cycle. The Role Involves Managing Documentation and collaborating with cross functional teams to ensure compliance throughout the Product Lifecycle. This job typically requires a degree or equivalent and a minimum of 2 or more years’ experience.

Who we want:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

• Delivers results.  A driven player who sets high goals for personal achievement and organizational success.  He/she measures success against the best internal and external benchmarks

What you will do:

• Review quality assurance documentation to support mainly product sustenance and regulatory submissions or new product development related to line extensions/custom made devices and product life cycle management.

• Support quality system maintenance and effectiveness by identifying and correcting deficiencies in procedures and practices.

• Execute risk management activities for NPI and Sustenance projects - Ensure that risk assessments are conducted in accordance with EUMDR requirements.

• Participate in design reviews by identifying risks associated with the product used and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development or legacy care process.

• Taking care of timely and quality deliverables for assigned projects.

• Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.

• Work closely with R&D, Clinical Affairs, Post Market, and other departments to integrate EUMDR compliance into product development processes.

What you need:

• B.Tech in Mechanical Engineering / Biomedical

• Experience: 2-6 years

• 2+ years’ experience in Design Quality Assurance (medical devices) or new product development

• In-depth knowledge of EUMDR requirements and other relevant regulations

• Relevant certifications in regulatory affairs or quality management may be beneficial.

• Excellent understanding of Quality Management Systems. (ISO 13485, 21 CRF 820)

• Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.

• AQE should drive coordination with different departments (such a R&D, Post Market Regulatory, Clinical) to ensure the resulting part/product/process is safe, compliant, and effective.

• Knowledge of EU MDR changes, ISO 14971, IEC 62366, Quality Concepts (e.g. CAPA, Audits, Statistics).

• Demonstrated ability to advocate for product excellence and quality.

• Strong experience in establishing world class risk methodologies for complex systems based upon existing corporate/divisional approaches.

• Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews and the other practices mentioned above.

Travel Percentage: 10%

Experience Level

Mid Level