Senior Quality Engineer
- Northborough, MA
- $115,000-135,000 per year
- Permanent
- Full-time
- Ensure Design Compliance: Oversee product designs to ensure compliance with regulatory standards (e.g., ISO 13485, FDA requirements) and company quality policies.
- Risk Management: Conduct risk assessments, including Failure Modes and Effects Analysis (FMEA), to identify and mitigate potential design and process risks.
- Design Validation and Verification: Lead validation and verification activities to confirm that products meet design specifications and intended use requirements.
- Quality Standards Implementation: Collaborate with design and engineering teams to integrate quality standards into the product development process.
- Process Improvement: Drive continuous improvement initiatives in design and manufacturing processes to enhance product quality and efficiency.
- Customer and Regulatory Support: Serve as a quality representative during customer audits and regulatory inspections, ensuring readiness and compliance.
- Documentation Management: Develop and maintain quality documentation, including design history files (DHFs) and technical reports.
- Problem Solving: Investigate and resolve design-related quality issues using root cause analysis and corrective action methodologies.
- Cross-Functional Collaboration: Partner with engineering, manufacturing, and project management teams to support product launches and resolve quality challenges.
- Hands on working on the production and manufacturing floor
- Strong Quality System Knowledge: Comprehensive understanding of quality management systems (ISO 13485, FDA regulations) and their application in medical device design.
- Technical Expertise: Solid foundation in engineering principles, design control processes, and risk management methodologies such as FMEA.
- Problem-Solving Skills: Proven ability to analyze complex design issues, identify root causes, and implement effective corrective actions.
- Attention to Detail: Meticulous in reviewing technical documentation, ensuring accuracy, and maintaining compliance with regulatory standards.
- Cross-Functional Collaboration: Skilled in working with diverse teams, including design, manufacturing, and quality, to achieve project goals.
- Project Management Ability: Strong organizational and time management skills to prioritize tasks and meet deadlines in a fast-paced environment.
- Innovative Mindset: Proactively identifies opportunities for process improvements and contributes to the advancement of product quality.
- Effective Communication: Excellent written and verbal communication skills for creating quality reports, presenting findings, and working with customers and stakeholders.
- Experience in Medical Devices: Prior experience in the medical device industry, particularly with product design and validation processes.
- Adaptability and Resilience: Capable of navigating challenges, adapting to change, and maintaining focus on quality and regulatory excellence.
- Competitive compensation & profit sharing
- Positive work culture
- 401(k) Retirement Plan: With employer matching contributions to help employees save for retirement.
- Health Insurance: Including medical, dental, and vision coverage to support overall well-being.
- Paid Time Off (PTO): Generous vacation, sick leave, and holiday pay.
- Life and Disability Insurance: Coverage for both short-term and long-term disabilities.
- Professional Development Opportunities: Training and advancement programs to help employees grow within the company.