- Collaborate at a systems level with R&D, Clinical, Data Analysis, and other key functions to develop a quantitative approach to risk management.
- Demonstrate expertise by leading cross-functional teams to identify risks, implement risk control measures, and document a robust and living Risk Management File.
- Facilitate the creation of both top-down and bottom-up risk management tools, assessments, processes, and principles, including FMEAs.
- Analyze existing similar products from the company and competitor products to provide documented compliance and evidence of State of the Art, as part of periodic risk management file updates.
- Assure products meet regulatory requirements for risk management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures.
- Ensure the systematic and logical conversion of customer requirements to product specifications and post market surveillance codes.
- Create and continually improve procedures and work instructions to ensure reliable, repeatable results. Support ongoing compliance improvement initiatives, including CAPAs across the five business groups in Connected Care.
location: Murrysville, Pennsylvania
job type: Contract
salary: $55.00 - 60.50 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- BS in Engineering or a related field. MS preferred.
- 6+ years Quality Assurance, Design Engineering, Systems Engineering, Post Market Surveillance, or related experience in a highly regulated industry.
- 2+ years experience with a MS or higher.
- Extensive hands on experience with the ISO 14971 standard.
- Knowledge of 21 CR 820, ISO 13485, IEC 60601-1, IEC 62366, and IEC 62304 standards.
- strong understanding of risk management requirements, tools, methodologies, and processes, including use of a variety of accepted methods.
- Demonstrated expertise in managing complex projects and implementing cultural change.
- Excellent customer service and interpersonal communication skills, including regularly leading presentations in front of peers and leadership.
- Experience working within a Quality Management System.
- Green Belt or Black Belt certification preferred.
qualifications:
- Experience level: Experienced
- Minimum 6 years of experience
- Education: Bachelors (required)
skills:
- Quality
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 Digital, 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 Digital 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.
