Our partner is looking for a Quality Engineer in Vernon Hills, IL.
The Quality Engineer is responsible for coordinating and verifying quality standards in accordance with the requirements of the organization. This position is offering a $1,500 Sign On Bonus.
REQUIREMENTS AND RESPONSIBILITIES:
- Develop and implement process flows in cooperation with functional groups.
- Create Metrics that drive effective monitoring of processes, value-add improvements and communication at all levels of the organization.
- Responsible for identifying and leading improvement projects.
- Organize investigation activities and coordinate appropriate resources to drive for root cause determinations, corrective action implementation and effectiveness verification.
- Ensure risk assessment activities are executed and maintained according to regulatory standards.
- Responsible for the validation of all required manufacturing processes in compliance with applicable internal and external requirements.
- Coordinate manufacturing process validation requirements, documentation and maintenance of validated processes with internal and external stakeholders.
- Perform validation training.
- Provide reports and data on assigned metrics.
- Create and update applicable procedures, work-instructions, forms, and other documentation as needed.
- Participate and support the ECO, CAPA, MRB and other Quality System processes.
- Provide documentation and support during audits.
- Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation - 21 CFR 820, GMP guidelines, GDP, ISO 13485, ISO 14971 and other regulatory requirements.
- Manage multiple, often concurrent projects and meet deadlines.
ADDITIONAL RESPONSIBILITIES:
- Aware of and comply with the RWMIC Quality Manual and applicable laws and regulations as they apply to this job type/position.
- Complete all planned Quality amp; Compliance training within the defined deadlines.
- Other duties as assigned by the US Head of Regulatory Affairs - QA/QC.
Requirements
- B.S. Degree in applicable technical discipline such as mechanical or biomedical engineering.
- 3-5 years' experience in the Medical Device industry is highly preferred.
- Relevant certifications demonstrating applied understanding of medical device quality system requirements, such as AAMI Quality System or sterilization certificates, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS) preferred.
- Applied understanding of statistical methods and tools, such as Six Sigma amp; Statistical Process Control.
- Excellent communication skills.
- Advanced PC knowledge and working experience with spreadsheets, presentations and report writing tools.
- Experience with and understanding of cross-cultural differences and the ability to work within this environment is crucial for successful employment.
- The following physical demands are required:
- Stand/Sit/Walk 8 hours per day
- The following work environment conditions may exist:
- Infectious Disease Exposure
- Chemicals Exposure
Benefits
- $1,500 Sign On Bonus
- 401k plan w/ company match
- Medical Insurance, Dental and Vision Insurance
- Company Paid Life amp; Disability Insurance
- Paid Time Off
- Paid Parental Leave
- Telecommuting
- Flexible Schedules
- Tuition Reimbursement
- Flexible Spending Accounts