Quality Engineer I Summary :
- Facilitating risk management assessments, updating risk plans and reports, consolidation and updating product system hazard analysis files in accordance with established company procedures and applicable standards
- Coordinate and facilitate meetings with cross functional stakeholders as needed to obtain information and data needed for completeness and accuracy of risk profiles for existing hazards, and identification of new risks and hazards as needed.
Escalate events to Management that require additional inputs or mitigations.
- Review and approve investigational documentation and ensure complaint workflows are complete and required supporting documentation is attached.
- Generating monthly metrics reports
- Analyze significant trends and coordinate mitigation with SMEs
- Present findings to complaint review boards and RAQA management
- Support a quality environment and mindset throughout the business by working closely with technical SMEs and global RAQA stakeholders to update and maintain product risk management files.
Upload risk management files into Veeva.
- Work closely with technical SMEs to ensure customer complaint investigation activities and files are completed and documented.
- Work closely with product experts (R&D, Marketing, Product Support and Manufacturing) to generate product quality metrics and analyze trends as required.
- Ability to work in an ever-shifting environment and possess a high level of patience to support cross functional teams with shifting priorities.
- A self-starter who can work independently and possesses a sense of ownership and accountability to the activities assigned to them.
Requirements :
- Bachelor’s degree or equivalent in a related technical or engineering discipline
- 1-2 years experience or equivalent combination of education and experience
- Basic knowledge of and application of principles and theories of quality engineering.
- Understanding of Medical Device / GMP / ISO regulations (ISO 14971, ISO 13485, MDSAP and FDA CFR Part 820), and FDA CFR Part 210 / 211 preferred.
- Basic understanding of risk management regulations, principles, and application.
- Excellent critical thinking, problem solving, coordination, teamwork, communication, technical and computer skills.
- SAP experience a plus.
- Proficient in Microsoft Office, Livelink, Visio.
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