Responsibilities
Key Responsibilities
- Be a part of sustaining project team and work in the design quality engineering across the entire product cycle.
- Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable)
- Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts (if required) for commercial products.
- Manage electronic document control and version control on all project related documents.
- Ensure adherence to the quality systems and design assurance SOPs and customer's PLCP.
- Provide quality and regulatory compliance guidance as needed to product development or design change project teams to assure country specific compliance to the laws and regulations of the targeted market for distribution.
- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
- Acts as an effective communicator or team member in supporting quality disciplines, decisions, and practices.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Customer's Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Job Scope and Leveling Guidelines
Functional Knowledge
- Requires expanded conceptual and technical and/or functional knowledge in Medical Device Design Quality domain.
- Broadens capabilities in applying concepts in job function.
Business Expertise
- Demonstrates working knowledge of business and industry practices and company processes to accomplish own work.
Leadership
- No supervisory responsibility; accountable for own contributions and meeting objectives.
- Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
Problem Solving
- Uses and exercises judgment to solve problems in straightforward situations and determine appropriate action/solutions.
- Works under general direction from more senior level roles/manager
Candidate should have 5+ years of experience
