Quality Engineer II

What You’ll Do

• Provide support for manufacturing commercial products through review and approval of Change Controls, CAPAs and Deviations.
• Support new product development as needed.
• Participate in customer and regulatory audits as part of the Audit Team.
• Track implementation of internal and external audits observations for on time closure.
• Work 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.

How You’ll Contribute

• 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.
• Evaluate and improve the above programs to ensure compliance with regulatory requirements.
• Perform internal audits as assigned and track implementation of audits observations for on time closure.
• Lead investigations, perform root cause analysis, prepare detailed investigation reports and implement corrective actions as needed.
• Perform QA review of new and revised procedures, technical protocols, validations and reports, as assigned.
• Participate as assigned in the development of customer requirements and design inputs; work with team to ensure that customer requirements (user needs) can be validated and design requirements can be verified.
• Facilitate the Risk Management Process in accordance with the latest version of ISO 14971; ensure integration of risk management outputs with design, process and regulatory requirements.
• Design and maintain procedures and systems for process and quality data collection.
• Conduct and/or support process capability evaluations and determine 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.
• Conduct gap analyses of in-house practices versus relevant regulations, standards and industry practices; develop plans and implement corrective actions to ensure continued compliance.
• Act as the SME trainer of other QA personnel.
• Perform other related duties as assigned.

What It Takes

• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Exercise 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.

What You Bring

• Bachelor’s Degree in engineering or equivalent experience.
• Minimum of 3 years related experience and demonstrated working knowledge of scientific principles in medical device manufacturing.
• Prior experience with review and approval of process change controls, CAPAs, Internal/External Audits.
• Strong knowledge of statistical process control methods and techniques.
• 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.

Compensation & Benefits

• The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting.
• Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location.
• Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more.
• At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.
• The compensation and benefits information is provided as of the date of this posting.
• Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.