You will be responsible for quality oversight of the design, development, and production of medical devices and combination products with a focus in the areas of risk mitigation, requirements definition, and verification and validation strategy and implementation.
Responsibilities:- Represent Quality in cross-functional development teams, providing direction for development through transfer to production activities.
- Author, maintain, and ensure compliance of Design History File documents during the development process in accordance with ISO 13485.
- Translate user needs, intended use, regulatory inputs, and risk controls into measurable product requirements, specifications, and acceptance criteria.
- Support design verification and validation activities, including statistical approach and analysis
- Support project related efforts with quality system elements (CAPA, Complaints, Supplier Management, External Audits, etc.).
- Participate in and facilitate risk management activities (hazard analysis, FMEAs, and risk assessments per ISO 14971)
- Ensure traceability and testability of design requirements and risk controls.
- Support manufacturing transfer, including review of preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans.
- Investigate, disposition, and resolve nonconforming material events during product development And pre-production phases; support production phases for transferred programs as needed.
- Act as technical expert (including potential author) for new or revised QMS procedures; May include train team members, and release quality system procedures, as required.
- Support internal and external audits (particularly for projects), as required with help of broader quality management team
- Support supplier selection, qualification, and ongoing monitoring with help of broader quality management team.
- Facilitate investigations to determine root cause and failure modes.
- Execute quality event initiation, investigation, and closure for nonconformances, CAPA, change control, and complaints as required.
Skills/Qualifications:- Able to work in the office at least 3 days a week
- Bachelor's degree in engineering, science, or relevant field
- 5+ years relevant work experience
- Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management system and requirements for medical devices and/or combination product development and manufacturing
- Proficiency with ISO 14971 and application of risk management to the development of medical devices and/or combination products
- Experience with electromechanical medical devices and IEC 60601 preferred
- Strong preference for experience in pharma or medical device manufacturing and/or development environment; Strong preference for electromechanical systems based experience
- Experience using risk analysis and continuous improvement concepts
- Experience with GxP requirements
- Experience supporting audits
- Strong technical written and verbal communication skills
- Excellent interpersonal, change management, planning, and organizational skills
- Excellent oral, written, and presentation communication skills
Personal Attributes:- Meets Gilero Core Values: Collaboration and Innovation of Excellence and Integrity
- Productive in a fast-paced, entrepreneurial environment.
- Commits to excellence and quality service to external and internal customers.
- Adheres to established policies and procedures, while contributing to continuous improvements.
Why work at Gilero?You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), dental and vision, company-provided life insurance, short-term and long-term disability, 401(k) with a match the first month after start date with a zero-vesting period, and access to LinkedIn learning for personal and professional development.
