Quality Engineer
| Company | LGC Group |
|---|---|
| Location | Gaithersburg, MD, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s Degree in a scientific discipline with experience in quality engineering.
- Minimum of 5 years in a cGMP or ISO 13485 environment, demonstrating a consistent record in quality-focused industries.
Responsibilities
- Lead site validation activities, ensuring flawless equipment qualification and process validations.
- Maintain Validation Master Plans and provide crucial support during IQ, OQ, and PQ stages, reviewing and implementing validation protocols and reports to uphold high standards.
- Coordinate site change orders, assessing risks to minimize impacts on processes, and collaborating with Manufacturing Operations, QC, and Technical Support.
- Investigate quality trends from complaints and NCRs, applying statistical techniques to identify root causes and implementing corrective actions.
- Review Document Change Requests, managing risk documentation and ensuring completeness of risk control actions.
Preferred Qualifications
- Proficient in interpreting FDA QSR regulations, ISO 13485, and ISO 14971, with extensive experience in validation and guiding various study types, including prospective, concurrent, and retrospective studies.
- Knowledgeable in statistical methods, quality control, and manufacturing operations, skilled in evaluating and resolving non-conformances, deviations, customer complaints, and CAPAs.
- Intermediate to advanced computer skills, including proficiency in word processing, spreadsheets, databases, ERP systems, and electronic quality management software.
- Strong interpersonal and organizational skills, both verbal and written, with a curious and adaptable approach, dedicated to teamwork and collaboration.
- Focused on problem-solving, possessing skills in risk evaluation and resolution, able to ask probing questions to identify root issues and facilitate discussions for consensus.
- Committed to continuous improvement, balancing control and flexibility based on risk, with strong analytical abilities for managing complex projects.
- Diligent and meticulous, capable of managing multiple tasks and meeting deadlines independently.