Quality Engineer II

ANIKA-GCC; Bedford (MA); On-site; USD 84,000 - 105,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Stock purchase plan

Job summary

Anika in Bedford, MA is seeking a Quality Engineer to support medical device manufacturing, CAPA/Change Controls and audit programs. You will collaborate with Operations, Manufacturing Engineering and R&D to ensure product quality and effective corrective actions.

The role involves leading investigations, risk management, document QA reviews and ensuring regulatory compliance (FDA/ISO). Strong writing and presentation skills are essential.

Qualifications

• Bachelor’s Degree in engineering or equivalent experience.
• Minimum of 3 years related experience in medical device manufacturing.
• Experience with review/approval of process change controls, CAPAs, Internal/External Audits.

Responsibilities

• Review and approve CAPAs, Change Controls; manage audit programs and tracking logs.
• Lead investigations, performs root cause analysis and implements corrective actions.
• Perform QA review of procedures, protocols, validations and reports.
• Support development of customer requirements and design inputs; verify design requirements.

Skills

Statistical process control

ISO 14971 Risk Management

Regulatory knowledge (FDA/ISO/QSR)

Quality system knowledge

Strong writing/presentation skills

Education

Bachelor’s Degree in engineering or equivalent experience

Tools

Electronic Quality Management System

Six Sigma

Job description

Job Description

What You’ll Do

The Quality Engineer will provide support for manufacturing commercial products through review and approval of Change Controls, CAPAs and Deviations. Support new product development as needed. The Quality Engineer participates in customer and regulatory audits as part of the Audit Teamtrack implementation of internal and external audits observations for on time closure. The Quality Engineer 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.

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.
• Evaluates and improves 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, performs root cause analysis, prepares 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; develops plans and implements 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.
• Requires a 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.
• 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.

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.

Position Details

• Location Bedford, MA
• Employment Type Full-Time
• Salary Range $84,000 – $105,000