Job Description
Sr. Quality Engineer with ISO 13485 and Medical Device Manufacturing experience needed for $100-120k! This Jobot Job is hosted by: Danielle McIntire
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Salary: $100,000 - $120,000 per year
A bit about us: We are a Medical Device Manufacturer headquartered in Staunton, VA, hiring for a Senior Quality Engineer ($100-120k annually) to join our team! We are seeking someone with 4+ years of Medical Device Manufacturing / Bio / Pharma experience well-versed in ISO 13485 regulations, owning CAPAs, FMEAs, control documentation and process validation, statistical analysis, and GD&T.
If this sounds like you, please apply TODAY! (Willing to pay for relocation assistance to Staunton, VA)
Why join us? Salary: $100-120k annually
Great Employee Tenure
Willing to pay relocation assistance to candidates not in the Staunton, VA area
Job Details Job Details:
We are seeking a highly skilled and experienced Permanent Sr. Quality Engineer to join our dynamic team. This role is crucial for our medical device manufacturing company, as it involves ensuring the quality and safety of our products. The successful candidate will be responsible for driving continuous improvement initiatives, conducting root cause analysis, and implementing corrective action plans. This is an exciting opportunity for a professional who is passionate about quality control and has a deep understanding of medical device regulations.
Responsibilities:
1. Develop, implement, and maintain quality engineering methodologies and systems.
2. Lead and participate in the design and development of medical devices, ensuring compliance with ISO 13485.
3. Conduct failure mode and effects analysis (FMEA) to identify potential risks and develop mitigation strategies.
4. Drive corrective and preventive action (CAPA) processes, ensuring timely resolution of quality issues.
5. Perform root cause analysis to identify and address the source of quality issues.
6. Participate in new product introduction (NPI) processes, ensuring quality considerations are integrated from the initial stages.
7. Collaborate with cross-functional teams to ensure the quality of products and compliance with regulatory requirements.
8. Lead internal and external audits, ensuring readiness and compliance with ISO standards.
9. Provide training and guidance to team members on quality systems and regulations.
10. Continually monitor and report on quality performance, identifying opportunities for improvement.
Qualifications:
1. Bachelor's degree in Engineering or a related field.
2. Minimum of 5 years of experience in quality engineering, preferably in the medical device manufacturing industry.
3. Certified Quality Engineer (CQE) certification from the American Society for Quality (ASQ) is preferred.
4. In-depth knowledge of ISO 13485, CAPA, FMEA, and root cause analysis.
5. Proven experience in leading and implementing quality improvement initiatives.
6. Excellent problem-solving skills with a strong attention to detail.
7. Strong communication and interpersonal skills, with the ability to work effectively in a team.
8. Proficient in using quality tools and software.
9. Ability to manage multiple tasks and projects, prioritizing as necessary to meet deadlines.
10. Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies, and tasks.
Interested in hearing more? Easy Apply now by clicking the "Apply" button.
Job Tags
Permanent employment, Relocation package,