Job Description Responsibilities:
Education & Experience:
- Manages the CAPAs, Change Controls, Internal and External Audit programs and maintain associated tracking logs. Has capability to manage these programs within the Electronic Quality Management system upon implementation.
- Evaluates and improve the above programs to ensure compliance with regulatory requirements.
- Performs internal and external audits as assigned and track implementation of audits observations for on time closure.
- Maintains the Approved Supplier List including updating and reviewing vendors performance as assigned.
- Leads investigations, performs root cause analysis, prepares detailed investigation reports and implements corrective actions as needed.
- Performs QA review of new and revised procedures, technical protocols, validations and reports as assigned.
- Participates as assigned 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
- Facilitates 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
- Designs and maintains 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.
- Support 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.
- Act as the SME trainer of other QA personnel.
- Performs other related duties as assigned
- Requires a Bachelor's Degree in engineering or related discipline with a minimum of 3 to 5 years related experience and demonstrated working knowledge of scientific principles.
- Prior experience with management of process change controls, CAPAs, Internal/External and Supplier Audits.
- Strong knowledge of statistical process control methods and techniques.
- Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices
- Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices.
- Knowledge of the FDA 21CFR, EU, TGA (Australia), ANVISA (Brazil)
- Working knowledge of cGMPs, QSRs, MDDs, MDR
- Familiarity with the principles of Design Control
- Working knowledge of Electronic Quality Management System.
- Working knowledge of Six Sigma a plus
- Strong writing and presentation skills
: 22-00328 : Bedford, MA: