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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Engineering for medical devices, ensuring compliance with regulatory standards such as ISO 13485 and 21-CFR-820. Capable of leading design assurance processes, mentoring teams, and developing innovative solutions to complex quality challenges.
Highest-signal resume keywords
Quality EngineeringDesign AssuranceRegulatory ComplianceCAPA ExpertiseProblem Solving
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Engineering ToolsStatisticsDesign ControlRisk ManagementProcess ValidationTest Method ValidationSupplier QualificationPost-Market SurveillanceChange ControlCTQ Identification
Soft Skills
Interpersonal SkillsLeadership SkillsCommunication SkillsMentoringCollaboration
Certifications & Qualifications
ASQ Certificate
Industry Keywords
ISO 1348521-CFR-820MDDMDRISO 14971ISO 10993CAPAQuality System AuditsDesign for Six SigmaRegulatory Standards
About the role
Key responsibilities & impact- Support new product development and product maintenance for medical devices using Quality engineering skills
- Handle projects and tasks from product inception through product launch and maintenance
- Ensure products meet quality standards, design control requirements, and regulatory requirements
- Provide support, mentoring, and coaching on technical principles, quality tools, and systems
- Develop technical solutions to complex problems
- Serve as a core team member for complex design control and process control projects
- Serve as a CAPA expert
- Modify methodologies and procedures to continuously improve outcomes
- Support quality system audits
- Provide input to the management review process
- Develop advanced technological ideas and guide their development into final products, processes, or business opportunities
- Ensure accurate and actionable data recording for decision-making and documentation of development work
- Contribute to long-range business strategies
- Support design control, EU MDD/MDR, change control, risk management, process validation, CTQ identification, deviations and non-conformances, test method validations, supplier qualification, post-market surveillance, CAPA root-cause investigations, sampling plans, and regulations and standards
- Liaise with manufacturing plants
- Provide functional support to cross-functional teams
- Support internal and external audits
- Mentor junior associates
- Participate in and potentially lead multidisciplinary projects
- Act as a site/functional subject matter expert
Requirements
What you’ll need- Bachelor’s Degree
- A minimum of 7 years of relevant experience or a combination of equivalent education and relevant experience
- Minimum 5 years of experience supporting design assurance for medical devices
- Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements
- Knowledge of applicable regulatory and industry standards, including 21-CFR-820, ISO 13485, MDD, MDR, ISO 14971, and ISO 10993
- Quality Engineering tools and statistics
- Problem solving skills
- Strong interpersonal, leadership, and communication skills
- ASQ Certificate(s) desirable (but not required)
- Design for Six Sigma preferred
Benefits
Comp & perks- Medical, dental, vision, health savings and flexible spending accounts
- Life and disability insurance
- Wellness resources
- Mental health support
- Disease management programs
- 401(k)
- Deferred compensation programs
- Financial counseling
- DailyPay
- Educational savings resources
- Paid time off
- Company holidays
- Educational assistance
- Parental leave
- Adoption assistance
- Backup care
- Caregiving support
- Employee assistance programs
- Commuter benefits
- Pet insurance
- Legal services
- Associate discount programs
- Bereavement, military, personal, family and medical leave, and jury duty leave
- Performance-based reward and recognition opportunities