Quality Systems Lead
3 weeks ago
About InnoTech Staffing
InnoTech Staffing is a staffing agency that specializes in placing top talent in various industries, including medical device manufacturing. We are currently seeking a highly experienced Medical Device Compliance Specialist to join our team.
About the Role
This is an exciting opportunity for a seasoned quality professional to lead and implement compliance programs within a dynamic medical device company. As a Medical Device Compliance Specialist, you will be responsible for ensuring compliance with relevant regulations, such as 21 CFR 820 and ISO 13485:2016. You will work closely with cross-functional teams to identify and mitigate risks associated with product development and manufacturing.
Responsibilities
- Develop and implement compliance policies and procedures to ensure regulatory compliance
- Conduct risk assessments and develop mitigation plans to address potential risks
- Collaborate with design and engineering teams to ensure that products meet quality and regulatory requirements
- Participate in internal and external audits to ensure compliance with quality management systems
- Identify and implement process improvements to enhance efficiency and effectiveness of compliance systems
Requirements
- Bachelor's degree in an engineering discipline or related field
- Minimum 5-8 years of experience in medical device quality engineering
- Proven track record of leading compliance program implementations and ensuring regulatory compliance
- Strong knowledge of quality management principles, including ISO 13485:2016 and 21 CFR 820
- Excellent communication and leadership skills
- Salary: $90,000 - $120,000 per year
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