East Walpole, United States
over 1 year ago
This role can be fulfilled in Walpole, MA; Tarrytown, NY; or Flanders, NJ
Supports the compliance via Corrective and Preventive Action (CAPA) system.
Develops and Maintains technical methods to improve Quality System tools, methods and processes.
Interfaces with multiple functions (internal customers) to understand needs and challenges. Plans and documents activities to service customer needs and improve quality system.
Manages and coordinates the maintenance of procedures and work instructions.
Issues the requirements for change request management in the projects and provides if necessary suitable methods.
Provides procedural support - Creation of quality notifications - Provision, maintenance and evaluation of processes (e.g. NCR, capa), together with the Quality-organization - Planning and execution of internal projects (e.g. lean) or events (e.g. capa) - Quality audits; supplier qualifications.
Acts independently from project management.
Needs experienced level of analytical and distinctive conceptual skills to solve issues, which may differ in size and nature. "Experienced Professional"
This position is expected to contribute to and deliver business processes or detailed technology solutions, in a self-managed and target oriented manner, and thus contributes to team results.
Targets are short to medium term (best to be characterized as milestones), and achievements are monitored.
Bachelor's Degree or equivalent (technical degree such as Biomedical / Engineering / Science / etc.) 0 to 3 years of relevant experience in their field of work and qualification.
Technical skills including Microsoft Office (Intermediate to Advanced Excel knowledge is required). Knowledge of Medical Device Industry regulations is preferred (ISO 13485 / CFR / etc.)
Knowledge of Quality Management Systems is preferred (CAPA / Nonconforming Product and Processes / Continuous Improvement / etc.).
SAP experience is helpful.
Focus on applying and expanding acquired knowledge base.