Quality Systems Engineer
Description For Quality Systems Engineer
Nextern is seeking a Senior Quality Systems Engineer to join their healthcare manufacturing team. This role is crucial in maintaining compliance with ISO 13485 and FDA regulations while driving continuous improvement in quality systems. The position offers a unique opportunity to lead quality initiatives, conduct audits, and implement innovative solutions in a medical device manufacturing environment. The ideal candidate will bring extensive experience in quality systems, strong leadership abilities, and a passion for maintaining the highest standards in medical device manufacturing. This role provides exposure to cutting-edge quality management systems and the chance to work with cross-functional teams globally. The position offers comprehensive benefits and professional development opportunities, making it an excellent choice for experienced quality professionals looking to advance their careers in the medical device industry. The role requires a combination of technical expertise, leadership skills, and regulatory knowledge, offering both challenges and opportunities for growth.
Responsibilities For Quality Systems Engineer
- Ensure compliance with ISO 13485 and 21CFR 820 Quality System regulations
- Oversee Issues Management and CAPA process
- Prepare quality metrics for management reviews
- Lead internal audits and host external audits
- Lead Quality System software validation
- Create and present professional training
- Monitor regulation changes
- Support QMS processes across all functions
- Identify and implement process improvements
- Support expansion of regulatory applications
Requirements For Quality Systems Engineer
- 8+ years in regulated manufacturing (medical device or pharmaceutical)
- ISO 13485 Lead Auditor certification preferred
- Bachelor's degree plus 4 years relevant experience, or minimum of 10 years in Quality Systems
- Experience with Agile PLM, Microsoft Power BI, Epicor ERP preferred
- Project management experience preferred
- Ability to travel internationally 1-2 times per year
- Strong communication and leadership skills
- Proficiency in problem-solving tools
- Advanced knowledge of change management and document control
Benefits For Quality Systems Engineer
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Free Food & Snacks
- Wellness Resources
