Location: Franklin, MA
Summary of Primary Responsibilities:
This position is responsible for providing manufacturing support for commercial products and new product development as needed. This technical role will support the manufacture of medical device and drug/device combination products by providing expertise on regulated standards processes such as design control, human factors/usability engineering, and risk management. Working closely with Operations, Manufacturing Engineering and Research and Development, the Quality Engineer ensures a high level of product quality and effective and efficient corrective and preventive action plans.
- Evaluates and help implements quality assurance programs and systems for manufacturing and product development to ensure compliance with regulatory requirements.
- Lead investigations, performs root cause analysis, prepares detailed investigation reports and implements corrective actions.
- Participate in change control meetings and review new change controls to ensure all aspect of the changes are in accordance with the product design inputs, outputs and existing validation requirements.
- Reviews protocols and reports to ensure quality attributes and analysis are being conducted.
- Participates in the development of customer requirements and design inputs; works with team to ensure that customer requirements (user needs) can be validated and design requirements can be verified.
- Applies the Risk Management Process in accordance with the latest version of ISO 14971; ensures integration of risk management outputs with design, process and regulatory requirements.
- Help design and maintain procedures and systems for process and quality data collection.
- Conducts and/or supports process capability evaluations and determines critical process control points and appropriate control limits.
- Participate in equipment and process validation methods to ensure they are properly validated prior to implementation and critical equipment is periodically re-validated.
- Conducts gap analyses of in-house practices versus relevant regulations, standards and industry practices; develops plans and implements corrective actions to ensure continued compliance.
- Perform internal audits and supplier audits as needed.
- Performs other related duties as assigned.
Works on problems of diverse and moderate scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting method and techniques for obtaining solutions. Requires knowledge of FDA, ISO, and other regulatory guidelines related to the manufacturing of medical devices.
No direct reports. Has responsibility to represent Quality Assurance in diverse teams as part of the implementation of projects.
Experience, Knowledge and Skills Required:
- Requires a Bachelor’s degree in Engineering or related discipline with a minimum of 2 to 5 years related experience and demonstrated working knowledge of scientific principles;
- Knowledge of statistical process control methods and techniques;
- Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices;
- Working knowledge of cGMPs, QSRs, MDDs and MDRs;
- Familiar with FDA, ISO 13485, MDSAP, TGA, ENVISA and other regulatory agency regulations.
- Familiarity with the principles of Design Control;
- Working knowledge of Six Sigma a plus;
- Strong writing and presentation skills;
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.