Engineer
Fresenius Kabi USA
full-time
Posted on:
Location Type: Office
Location: Warrendale • Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $70,000 - $75,000 per year
Job Level
Junior
About the role
- Analyze and execute processes to ensure product quality in the Production Unit (PU)
- Support core quality system processes to ensure compliance with applicable medical device regulations and standards (FDA, EU, Health Canada, ISO 13485)
- Provide operations assistance, track quality metrics, review and approve quality system records, and analyze data
- Work in a cross-functional team environment
- Apply engineering principles to resolve difficult problems
- Ensure design transfer compliance through active team membership
- Manage the change order process and provide quality engineering support for device manufacturing
- Initiate and manage CAPA records
- Collaborate with other departments and cross-functional teams to support investigations and root cause analyses
- Support and/or participate in internal and external audits
- Compile and analyze various quality metrics
Requirements
- B.S. degree in Engineering (Mechanical, Electrical, Biomedical preferred)
- Proficiency with Microsoft Word, Excel, and PowerPoint
- 0-3 years of experience in the medical device or pharmaceutical industry preferred (quality engineering and/or product development experience a plus)
- Knowledge of lean manufacturing, Six Sigma, and Project Management principles a plus
- Knowledge of quality systems requirements (e.g. 21 CFR Part 820, ISO 13485, etc.) a plus
- Knowledge of quality control processes and statistical techniques
- Strong analytical problem-solving skills
- Strong attention to detail
- Excellent verbal and written communication skills
- Strong interpersonal skills and the ability to work with cross-functional teams
Benefits
- 401(k) plan with company contributions
- Paid vacation
- Holiday and personal days
- Employee assistance program
- Health benefits to include medical, prescription drug, dental and vision
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality engineeringdata analysisstatistical techniqueslean manufacturingSix Sigmaproject managementdesign transfer complianceCAPA managementquality control processesengineering principles
Soft skills
analytical problem-solvingattention to detailverbal communicationwritten communicationinterpersonal skillscollaborationcross-functional teamwork