Summary of Primary Responsibilities:
This position is responsible for providing support for manufacturing support for commercial products through review and approval of Process Change Controls, CAPAs and Deviations. Support new product development as needed. Performs Internal audits as assigned. Participates in customer and regulatory audits as part of the Audit Team; maintain the Design History Files (DHF), Design Master Records (DMR); track implementation of internal and external audits observations for on time closure.
Works closely with Operations, Manufacturing Engineering and Research & Development to ensure manufacturing of effective and high-level product quality, while ensuring implementation of efficient corrective and preventive action plans. Works with other business units’ quality functions to identify areas where compliance input and escalation is required to ensure consistency in the application of criteria across Anika.
- Review and approve CAPAs, Change Controls. Manage 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 audits as assigned and track implementation of audits observations for on time closure.
- 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
Works on problems of diverse 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 thorough knowledge of FDA, ISO, and other regulatory guidelines related to the manufacturing of medical devices.
No direct reports. Has responsibility to oversee diverse teams in the implementation of projects.
Experience, Knowledge and Skills Required:
- Requires a Bachelor’s Degree in engineering or related discipline with a minimum of 5 years related experience and demonstrated working knowledge of scientific principles.
- Prior experience with review and approval of process change controls, CAPAs, Internal/External 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
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.