· This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support new product development projects and lead completion of design control deliverables, such as design verification, design validation and risk management.
· Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Design Quality function as a Core Team Member)
· Lead on-time completion of Design Control Deliverables
· Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
· Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities
· Lead or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis
· Support design test and inspection method development, and lead test method validation activities
· Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating, and resolving gaps
· Support manufacturing process development and qualification for new product commercialization and product changes
· Support internal and external audit responses and on-time product re-certifications
· Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
· Support and ensure objective component specification definitions
· Support the development and review of biocompatibility and sterilization validations
· Supports R&D product builds for bench testing, animal lab, and first in human activities.
· Complete Document Change Request Reviews in a timely and objective manner
· Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required.
· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
· Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
· Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
· Additional duties may be identified by functional management based on the current project/business objectives.
· Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Requirements
· Bachelor's degree within an Engineering field or related science-based discipline.
· 2-5 years of related work experience.
· Previous Quality engineering experience and demonstrated use of Quality tools/methodologies.
· Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
· Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
· Ability to leverage and/or engage others to accomplish projects.
· Strong organizational and follow-up skills, as well as attention to detail.
Preferred Qualifications:
· Advanced degree in a technical field.
· Medical device experience is a plus.
· Experience working in a broader enterprise/cross-division business unit model.
· ISO 13485 Quality Management System,21 CFR Part 820 FDA Quality System Regulations ISO 14971,EUMDR,MDSAP is a plus.
· Good Manufacturing Practices and Good Documentation Practices.
As an equal opportunity employer, ICONMA prides itself on creating an employment environment that supports and encourages the abilities of all persons regardless of race, color, gender, age, sexual orientation, citizenship, or disability.