Validation Engineer - Military Veterans
at Randstad Engineering
job summary:
A Validation Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in neurosurgery, and reconstructive and general surgery. Remote work. This position is responsible for overseeing and guiding supplier process validations (IQ/OQ/PQ) for sterile barrier packaging manufacturing, ensuring compliance with FDA, ISO 13485, and ISO 11607 standards while collaborating with suppliers to execute validation requirements and resolve technical challenges.
location: Remote, Remote
job type: Contract
salary: $39.99 - 55.86 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Collaborate with suppliers to review and approve validation documentation, including protocols and reports.
- Provide hands-on support to suppliers during validation activities, ensuring compliance with regulatory standards (FDA, ISO 13485).
- Lead technical discussions with suppliers to address validation challenges and resolve issues.
- Coordinate post-design verification activities, including updates to engineering drawings to reflect CTQs and associated risk levels.
- Deliver progress updates to internal stakeholders, ensuring alignment with program timelines and quality standards.
- Conduct focused process audits to evaluate supplier compliance with validation protocols.
Skills:
- strong understanding of sterile barrier packaging materials and manufacturing processes.
- Proficiency in regulatory standards, including FDA, ISO 13485, and ISO 11607.
- Experience with technical drawings, CTQs, and risk management principles.
- strong analytical skills with experience using data for validation decisions.
- Ability to work collaboratively with suppliers and cross-functional teams.
Education and Experience:
- Degree in Mechanical, Industrial Engineering, or a related Science discipline.
- 8+ years of experience in process validation (IQ/OQ/PQ) within a regulated industry (medical devices, pharmaceuticals).
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qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Bachelors
Princeton, NJ
Randstad is a $22.5 billion global provider of HR services and the second largest staffing organization in the world. From temporary staffing to permanent placement to inhouse, professionals, search & selection, and HR Solutions, Randstad holds top positions around the world and has approximately 31,100 corporate employees working from its nearly 4,700 branches and inhouse locations in 40 countries. Founded in 1960 and headquartered in Diemen, the Netherlands, Randstad Holding nv is listed on the NYSE Euronext Amsterdam (RAND.AS).