Bachelor's degree in Engineering or equivalent experience
5+ years of quality engineering experience
Excellent communication skills across multiple organizational levels
Strong analytical and problem-solving skills
Advanced computer skills for data analysis and reporting
Master's degree in Engineering (preferred)
Experience in medical device design (preferred)
Familiarity with FDA and ISO standards (preferred)
Responsibilities
Serve on product development teams to ensure quality standards are met
Execute Design Control deliverables for various projects
Collaborate with teams on Design Control processes
Support the establishment of measurable customer and product requirements
Conduct product development equipment qualifications and inspections
Review and approve validation deliverables per FDA and ISO standards
Lead Risk Management activities for development projects
Maintain Risk Management documentation
Apply problem-solving methods to resolve quality issues
Ensure compliance with quality management and environmental systems
Benefits
Collaborative work environment
Opportunities for professional development
Involvement in innovative product development
Focus on patient and user safety
Contribute to industry-leading quality standards
Full Job Description
Job Summary:
The Sr. Design Quality Engineer is responsible for ensuring new or modified products conform to established quality standards and comply with the quality system.
This role partners closely with cross-functional teams to promote quality throughout product development, protect patient and user safety, and support business objectives while maintaining compliance with FDA and applicable regulatory and ISO standards.
Roles & Responsibilities:
Serve on product development teams to promote and assure quality in product development projects.
Execute and support on-time completion of Design Control deliverables for Design Change, Clinical, and New Product Development projects.
Work with cross-functional teams to execute and support Design Control processes, including Design Inputs, Design Outputs, Design Verification, and Design Validation.
Support the assessment and establishment of objective, measurable, discrete, and verifiable customer and product requirements.
Support product development equipment qualification activities and inspection method development and validation activities.
Review and approve design, development, and verification/validation deliverables in compliance with FDA QSR requirements and applicable ISO standards for implantable medical devices.
Be accountable for Applicable Standards Documents and checklists, Labeling Verification planning and execution, Essential Output reports, and General Safety and Performance Requirements (GSPR).
Ensure Design History File (DHF) content completion, integrity, and compliance with regulatory and standards requirements; collaboratively communicate and resolve gaps.
Lead Risk Management activities for development projects and supplier change requests, including creation and maintenance of risk assessments, risk management plans/reports, hazard analysis, and Failure Mode Effects & Criticality Analysis (FMECA).
Maintain Risk Management deliverables to ensure continued acceptability of products based on post-market feedback.
pply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors at all levels.
Support company initiatives related to Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Education & Experience:
Bachelor's Degree in Engineering, a technical field, or an equivalent combination of education and work experience.
5+ years of quality engineering experience with demonstrated use of quality tools and methodologies.
Excellent verbal, written, and interpersonal communication skills with the ability to communicate effectively at multiple organizational levels.
Strong analytical, problem-solving, critical thinking, and presentation skills.
Demonstrated initiative, ownership, and accountability with the ability to plan, prioritize, and meet deadlines.
dvanced computer skills, including statistical and data analysis and report writing.
Master's Degree in Engineering or a technical field (preferred).
Previous medical device design and development experience (preferred).
Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-1, ISO 14708, EU MDR, and related standards (preferred).
