Product Development Quality Assurance Expert

3 weeks ago


Southborough, Massachusetts, United States Michael Page Full time
Job Description:

We are seeking a Product Development Quality Assurance Expert to join our team at Michael Page.

About the Role:
  • The successful candidate will lead Design Assurance activities throughout the product life cycle.
  • They will provide expertise in Risk Management, Design Verification/Validation, Test Method Validation, and Process Validation.
  • The Product Development Quality Assurance Expert will apply systematic problem-solving methodologies to resolve quality issues.
Responsibilities:
  • Lead Design Assurance activities throughout the product life cycle.
  • Provide expertise in Risk Management, Design Verification/Validation, Test Method Validation, and Process Validation.
  • Apply systematic problem-solving methodologies to resolve quality issues.
  • Stay current on regulatory requirements and standards for medical device development.
  • Guide engineering team members and ensure adherence to design controls.
  • Support complaint handling and CAPA processes as needed.
  • Collaborate with R&D to develop project protocols and solutions.
  • Work with suppliers and supplier quality teams to ensure product quality.
  • Develop and implement appropriate test methods and validations.
  • Oversee statistical methods for design and process optimization.
  • Ensure compliance with industry standards and best practices.
  • Perform additional responsibilities as needed for project success.
  • Be onsite at our Southborough, MA facility daily.
Requirements:
  • Bachelor's degree in science or engineering with 5+ years of experience in quality management within medical devices or life sciences.
  • Prior experience as a Quality Engineer / Design Quality Engineer for a minimum of 3 years is preferred.
  • Preferred background in electrical engineering, with experience in US Class III medical devices.
  • Experience in cardiac electrophysiology devices is a plus.
  • Strong leadership skills with the ability to manage and guide teams.
  • Expertise in risk management, design verification and validation, and test method validation.
  • Knowledge of process validation and preparation.
  • Proficient in statistical methods and design controls.
  • Ability to solve complex problems and make data-driven decisions.
  • Strong communication skills, able to write and speak clearly across organizational levels.
  • Experience working through the entire product life cycle.
  • Familiarity with protocols and compliance standards.
  • Efficient in planning, prioritizing, and organizing tasks and team activities.
  • Local to Southborough, MA.
What We Offer:
  • Growth-focused company with multiple ongoing projects.


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