The Senior Design Quality Engineer ensures the highest quality standards for advanced micromanufactured components used in medical devices, focusing on compliance, process improvement, and defect prevention. The role involvescollaborating with cross-functional teams to develop and validate robust quality systems, driving innovation in medical device manufacturing. Client DetailsMy client is a leader in the manufacturing of catheters within medical device manufacturing. The company provides cutting-edge solutions, specializing in the production of intricate components that play a critical role in improving healthcare outcomes. My client is known for its commitment to quality, precision, and customer satisfaction, ensuring that its products meet the highest industry standards. Employees benefit from a collaborative and innovative work environment, where their contributions are valued and celebrated.The company places a strong emphasis on professional growth, offering training, mentorship, and career development opportunities. My client fosters a culture of teamwork and inclusivity, creating an atmosphere where ideas and innovation thrive. With state-of-the-art facilities and a focus on sustainability, this specific location exemplifies my clients' dedication to excellence. For those passionate about making a meaningful impact in the medical device industry, this is an inspiring and rewarding place to build a career.DescriptionSenior Design Quality Engineer:
- 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.ProfileSenior Design Quality Engineer:
- 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.Job Offer
- 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.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.