AP Professionals Published: September 25, 2017 (25 days ago)
Quality Systems Engineer
Direct hire, east side location, 80 - 100K depending on experience
- Drive the implementation of QMS tools and technologies to enhance compliance to current standards, regulations, and corporate requirements.
- Contribute to and execute a strategy for the implementation of QMS initiatives.
- Drive initiatives to improve usability of QMS procedures and instructions.
- Facilitate improvements of the QMS and provide training in GMS and Good Manufacturing Practices (GMP).
- Manage and improve the CAPA process acting as the sites CAPA coordinator.
- Manage the internal audit process.
- Host and follow up on notified body audits.
- Project manager/representative on implementation of new eQMS activities.
- Manage current paper and eQMS systems.
- Create and coordinate creation of key procedures and processes based on feedback, set quality goals, and to ensure customer agreement fulfillment.
- Support internal functional partners and ensure all aspects of the QMS are understood, implemented, and maintained.
Skills / Abilities
- Well organized and structured.
- Possess strong analytic and problem solving skills.
- Excellent ability to write documents and describe processes and procedures.
- Attention to detail with good understanding of the big picture.
Education / Experience
- Bachelor's degree in science or technology, or equivalent three to five years' of experience.
- Working experience with ISO 13485 required.
- Working experience with medical device regulations (i.e. MDD 93/42/EEC, FDA 21 CFR Part 820) preferred.
- Experience in auditing techniques as well as interpreting and transforming requirements to practical implementation.