Civil Engineer EIT/PE (Wilmington)
Are you a fit? Easy Apply now by clicking the Apply button and sending us your resume.
Salary: $65 - $85 per hour A bit about us: We are a leading medical device company that operates privately and is committed to enhancing the care and quality of life of patients with kidney disease. Our goal is to create cutting-edge solutions that enable patients and their healthcare providers to manage kidney disease with ease. Why join us?
- Company Equity!
- Excellent medical, dental, & vision package!
- 401(k) with a match!
- Generous PTO!
- Opportunity to make a difference in people's lives!
2. Analyze and manage Corrective and Preventive Actions (CAPA) to ensure effective resolution of quality issues.
3. Utilize problem-solving methodologies such as Fishbone or DMAIC to identify root causes and implement corrective actions.
4. Maintain the FDA Quality Management System Reporting (QMSR) and ensure that all quality metrics are met or exceeded.
5. Provide consultation to various departments on quality systems, regulatory compliance, and risk management.
6. Conduct internal and external audits to ensure compliance with regulatory standards.
7. Lead and oversee post-market surveillance programs.
8. Collaborate with cross-functional teams to drive continuous improvement initiatives.
9. Lead the review and approval of design and process changes, ensuring compliance with quality standards and regulatory requirements. Qualifications: 1. Bachelor's degree in Engineering, Quality Assurance, or a related field is required.
2. Minimum of 12 years of experience in a quality engineering role with strong medical device industry experience.
3. Extensive knowledge of FDA regulations, ISO 13485, Fishbone, DMAIC, 8D, and/or FDA QMSR.
4. Expertise in post-market quality system activities including complaint handling, vigilance/adverse event reporting, HHE, and post-market surveillance.
5. Conduct and lead complex investigations and implement CAPA.
6. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred. Interested in hearing more? Easy Apply now by clicking the Apply button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot’s policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy
Recommended Jobs
Pre-Construction Estimator - HVAC/Mechanical Systems
Maintenance Supervisor – Fresh Meat Fabrication Shift: 2nd Shift Type: Regular Full-Time – Salaried Job Summary The Maintenance Supervisor must have knowledge of General Maintenance, Hy…
Machinist Apprenticeship
Job Description Summary Job Description JOB OVERVIEW The role involves the manufacturing of rotating jet engine components, working with unique aerospace alloys on some of the latest CNC mac…
CST Team Lead
Bring Your Passion. Appalachian Community Services (ACS), an ncgCARE partner, is dedicated to providing mental health, substance use, and intellectual/developmental disability services to individual…
OSP Director of Construction
The Director of Construction is responsible for leading all aspects of OSP construction operations, including planning, budgeting, resource allocation, project execution, vendor management, and ensur…
Operations Leader
Sephora is seeking an Operations Leader in Durham, United States, to drive operational excellence and support an exceptional client experience. This full-time role involves overseeing inventory manage…
Bilingual Caregiver [English/Spanish]
Job Description Job Description Benefits: Competitive salary Flexible schedule Training & development Benefits/Perks Flexible Scheduling Competitive Compensation Careers Adva…
Housekeeper
The position will be available in November 2025 in my mansion, in the Dominican Republic.
Conservation Crew Member
Interested in gaining skills in conservation and natural resource management while helping to protect our public lands and environment? Join American Conservation Experience (ACE) and receive free ho…
PMO Manager
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding bel…
Veterinary Extern - Animal Care of Greenville
Overview: &##128062; Calling All Vet Med Students: Your Greenville Adventure Awaits! &##128062; Externship at Animal Care of Greenville Looking for an externship that’s more than just shadowi…