Job details
Salary $70 - $75 an hour job type full-time contract number of hires for this role 1
Qualifications
Bachelor`s (required)
Risk management: 6 years (required)
Prha and fmea: 6 years (required)
Us work authorization (required)
Full job description
Responsibilities:
Ensures quality risk management files are in alignment with 21cfr part 820 design control and risk management requirements of iso 14971 for all amgen commercialized combination products.
Creates and maintains the rmf’s.
Conducts risk assessments and creates/revises risk management documents as required by standard operating procedures, fda, eu and other medical device and combination product regulations.
Management of hazard analyses, design risk assessments, use risk assessments, system risk assessments, and process risk assessments for combination products with manual, mechanical or electromechanical device constituent parts.
Actively collaborates with design engineers to drive design mitigations and establish effectiveness of the risk control measures
Leads periodic and event driven risk reviews of the rmf’s for commercialized products
Supports the complaints intake teams with assessment of risks related to reported complaints
Supports the medical safety teams with assessment and responses to regulatory agencies and competent authorities related to medical device reporting requirements
Successfully influences outcomes, communicates with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metrics generation and reporting
Understands manufacturing processes for amgen’s packaged and/or distributed products
Supports root cause analysis of complaint investigations
Basic qualifications
Doctorate degree; or
Master’s degree and 3 years of risk management or engineering experience; or
Bachelor’s degree and 5 years of risk management or engineering experience; or
Associate’s degree and 10 years of risk management or engineering experience; or
High school diploma/ged and 12 years of risk management or engineering experience
Preferred qualifications
Bachelor’s or master’s degree in engineering, preferred mechanical engineering, electrical engineering, systems engineering, materials engineering, or bio-medical engineering.
6 or more years of experience with risk analysis methods such as prha and fmea for medical devices
5 or more years of experience in a medical device development or device risk management role
3 or more years of experience with medical device reporting requirements, preferably for the european union
Experience with risk management per iso 14971
Experience is leadership role(s) and working with cross functional groups
Experience working with complaints intake and complaints investigation teams
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to converse technically with mechanical, electronic, software, and quality engineers
Capable of managing multiple projects in a deadline driven environment
Strong technical writing and interpersonal skills
Amgen strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save livesIn everything we do, we aim to fulfill our mission to serve patientsAnd every step of the way, we are guided by the values that define us.
Top 3 must have skill sets:
1Risk management experience
2Regulated industry experience (medical, aerospace, defense, etc.)
3Good communication skills
Job types: full-time, contract
Salary: $70.00 - $75.00 per hour
Schedule:
8 hour shift
Education:
Bachelor`s (required)
Experience:
Risk management: 6 years (required)
Prha and fmea: 6 years (required)
Medical device: 6 years (required)
Work location:
Fully remote
Work location: remote
