Validation Engineer *$1,500 Sign On Bonus*
Company: RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
Location: Vernon Hills
Posted on: May 14, 2022
Job Description*$1,500 Sign On Bonus*Richard Wolf Medical
Instruments Corporation is currently seeking a Validation Engineer
in Vernon Hills, IL. The Validation Engineer is responsible for
coordinating and verifying quality standards in accordance with the
requirements of the organization. REQUIREMENTS AND
- Responsible for the validation of all required manufacturing
processes in compliance with applicable internal and external
- Coordinates manufacturing process validation requirements and
documentation with internal and external stakeholders.
- Supports the update and maintenance of validated processes
- Supports validation training.
- Builds, organizes, and maintains databases and/or logs of
actions completed, pending actions, and current status
- Provides reports and data on assigned metrics.
- Creates and updates applicable procedures, work-instructions,
forms, and other documentation as needed.
- Participates and supports ECO, CAPA, MRB and other Quality
- Provides 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
- Manages multiple, often concurrent projects and meets
- Coordinates acquisition of cross-functional resources.
- Aware of and complies with the RWMIC Quality Manual and
applicable laws and regulations as they apply to this job
- Completes all planned Quality & Compliance training within the
- Other duties as assigned by Quality Assurance Manager or US
Head of Regulatory Affairs – QA/QC. QUALIFICATIONS:(ONLY QUALIFIED
CANDIDATES WILL BE CONSIDERED)
- B.S. Degree in applicable technical discipline, such as
mechanical, bio-medical or chemical engineering, required
- Relevant experience or certifications demonstrating applied
understanding of medical device quality system requirements, such
asAAMI Quality System or sterilization certificates, Certified ASQ
or ISO Lead Auditor and Regulatory Affairs Professional Society
- Applied understanding of statistical methods and tools, such as
Six Sigma & Mini Tab required.
- 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
- 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
- RWMIC offers annual Immunizations for Hep B and Flu Shots to
all RWMIC employees. RWMIC employees have the responsibility to
themselves and the company to consider receiving these
- All RWMIC Employees have the responsibility to themselves and
the company to work safely. We offer competitive wages and a
comprehensive benefits package, which includes:
- 401 (k) Retirement Savings Plan and Trust w/Matching
- Medical Insurance, Dental and Vision Insurance
- Company Paid Life & Disability Insurance
- Paid Time Off
- Paid Parental Leave
- Flexible Schedules
- Tuition Reimbursement
- Wellness Program
- Flexible Spending Accounts
- Unpaid Time Off
- Backup CareAt Richard Wolf Medical Instruments Corporation
("RWMIC"), we are committed to maintaining an environment of Equal
Opportunity and Affirmative Action.
Keywords: RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, Arlington Heights , Validation Engineer *$1,500 Sign On Bonus*, Engineering , Vernon Hills, Illinois
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