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Regulatory Compliance Engineer

2 months ago

Grand Rapids, Michigan, United States Jobot Full time
Join Jobot as a Quality Engineer in the Medical Device Sector

We are excited to announce an opening for a Quality Engineer at Jobot, a frontrunner in the field of precision-engineered medical products. This role is essential in maintaining the high standards of quality and reliability that our products are known for, leveraging your expertise in manufacturing processes, problem-solving techniques, and adherence to regulatory standards.

About Jobot:

Jobot stands out as a national leader in the precision manufacturing of medical implants and surgical instruments. Our dedication to fostering a collaborative work environment, prioritizing employee well-being, and emphasizing technical excellence makes us a sought-after employer in the industry.

Key Responsibilities:

- Oversee APQP and PPAP processes for new product introductions and modifications in manufacturing
- Provide insights on design for manufacturability enhancements
- Conduct R&D to validate processes and ensure regulatory compliance
- Create technical documentation for manufacturing protocols
- Implement metrology and GD&T for quality assessments
- Assess equipment for potential improvements and facilitate acquisition
- Employ statistical analysis for process capability and control
- Lead initiatives for quality enhancement using lean manufacturing methodologies
- Drive corrective and preventive measures to uphold product quality
- Ensure adherence to ISO and FDA regulations
- Collaborate with suppliers and offer technical support to production teams

Qualifications:
  • At least 5 years of experience in manufacturing
  • Familiarity with ISO 9000 standards
  • Strong analytical and problem-solving abilities
  • Capability to excel in a dynamic work environment
Preferred Qualifications:
  • Certifications such as Green Belt or ASQ
  • Degree in Engineering or a related field
  • Experience with GMP in the medical device industry
Skills and Competencies:
  • Excellent interpersonal and presentation skills
  • Proficiency in SolidWorks and Microsoft Office Suite
  • Experience in project management and lean manufacturing principles
  • Ability to work effectively in a team setting