- 176397 - EU MDR Remediation Workstream Lead
- 16 months
- Chipton Ross is seeking an EU MDR Remediation Workstream Lead in Acton, MA.
KEY REPONSIBILITIES INCLUDE: Planning and controlling project to remediate design history file documentation for medical devices
- Works with departmental managers, leaders and subject matter experts to review and assist in creating documentation that will support product testing, data collection, risk management and process flow
- Performs gap analysis of current practices and procedures
- Create, update and maintain trending charts as requested - Other projects or tasks as assigned
Requirements for this position are but not limited to:
EDUCATION and/or EXPERIENCE:
- Bachelor's Degree in Engineering
- 10-15 years' experience working as a system engineer in a product development environment
SKILLS, KNOWLEDGE AND EXPERIENCE
REQUIRED: Strong computer skills and knowledge of MS Word, MS Excel, Access, Outlook and MS Visio
- MS Project scheduling is desired
- Must have strong verbal and interpersonal communication skills
- Strong English writing, editing and grammar skills
- Excellent organizational, planning and project management skills
- Must display a positive attitude while maintaining flexibility
- Team player with ability to facilitate meetings with cross functional teams located on site and abroad.
QUALITY AND REGULATORY REQUIREMENTS: Quality system knowledge including Design History File Knowledge, labeling
- Establishes, implements and maintains the quality system in accordance to FDA Regulations, ISO 13485, European Union Medical Device Directive
- Completes and documents all required quality, business and departmental training
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x307 or (800) 927-9318 x307
Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.
Employment will be contingent on candidate clearing pre-employment drug screen and background check.
Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.