San Francisco Bay Area, CA
Senior QE (Analytical Chemistry)
Initiate, monitor, support and evaluate quality system activities. Participate as quality team member in product design and manufacturing efforts, including commercial products and combination device program. Comprehend quality engineering principles, theories, concepts practices and techniques. Continue to develop expertise in areas of specialization. Analyze and participate in solving problems using creative and effective techniques or processes.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Comply with the Company’s quality system requirements and other applicable regulatory requirements.
- Participate in developing quality activities – incoming quality inspection instructions, in-process inspection instructions, test method optimization, post-sterilization release inspection and non-conforming material analysis.
- Support process validation, conducting test method validation and write protocols and reports in conjunction with verification and validation testing.
- Perform and analyze primary analytical techniques of HPLC, UV, and other wet-chemistry related tests to support development and production activities.
- Provide engineering support to manufacturing and R&D (product development).
- Regulation/standard identification, sterilization and packaging validations, expiry date determination, standard test methods and design of experiments.
- Maintain schedules, identify and recommend solutions to specific aspects of a project.
- Investigate root cause and coordinates corrective action to audit findings.
- Responsible for all complaint and investigations
- Recommend changes to existing internal system to improve the quality aspect of the product development process.
- Perform statistical evaluation of data pertaining to field returns, non-conforming product identified by production and supplier quality in order to identify areas for improvement. Present all quality control trends
- Train others, primarily assembles and technicians in the implementation of solutions.
- Participate in the development of FMEA and other risk assessment documentation.
- Ensure compliance with all ISO, ASTM, ICH, USP, EN, MDD and FDA regulations and requirements.
QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):
- BS in Engineering required; MS preferred.
- 4 – 6 years industry experience in the medical device manufacturing field, including combination products.
- Analytical chemistry background required.
- Good communication skills, both written and oral.
- Knowledge of and experience in manufacturing medical devices in conformance with Quality System Regulation and ISO 13845 requirements.
- Good knowledge of statistical analysis including SPC