Seeking a Quality Assurance Senior Specialist to support the Digital Quality Management System (QMS) Transformation initiative. This role is an exciting opportunity to help design, streamline, and sustain a next-generation QMS that will modernize and unify quality operations across R&D and Manufacturing.
You'll collaborate globally to implement and maintain digital QMS processes, ensuring compliance with FDA, ISO, and EU quality system regulations while driving inspection readiness and process improvement.
location: Telecommute
job type: Contract
salary: $35.00 - 40.81 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Manage the collaboration on the process improvement, transfer and sustainment of QMS processes, across Company Operations and R&D, to the Digital QMS platform for health and control processes.
- Leads Digital QMS audit & inspection readiness, deviations and change control activities
- Manage Organizational Change Management (OCM) activities and Training deliverables that support the Digital QMS Maintain knowledge of current systems, tools, standard methodologies, and terminology and ensure adherence to GxP (GMP, GDP, GCP, GLP & GPvP) and other applicable regulations
- Manages and provides oversight of documents / records within the Quality Management System
- Oversight of process key performance indicators and metrics
- Manages external contractors providing services to the Digital QMS
- Working across teams managing priorities
qualifications:
- Doctorate degree and 2 years of experience or Master degree and 6 years of experience or Bachelor degree and 8 years of experience or Associate degree and 10 years of experience or high school diploma / GED and 12 years of experience
- Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards
- Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (e.g. FDA CFRs for Biologics and Medical Devices, FDA Combination Product Regulation, ISO:13845, EU Medical Device Directive, EN 60601and IEC/EN 62304)
- Experience supporting pre-clinical, clinical research, and/or pharmacovigilance activities Ability to read, analyzes, and interprets general business periodicals, professional journals, technical procedures, or governmental regulations
- Experience with risk-based Supplier Quality Management process.
- Management of Global Inspection and Audit programs
- Proficient working on multiple projects in a deadline driven environment
- Strong decision making and organization skills with the ability to prioritize multiple business priorities.
- Experience in project management, process improvement and quality system management
- Effective verbal and written communication skills (writing and presentations) in English
skills: Quality Assurance, Regulatory Inspection Readiness, Quality Assurance (QA), Medical Device, Food and Drug Administration (FDA), Quality Management Systems (QMS)
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
