Anika · 4 hours ago
Quality Engineer II
Bedford, MA
Full-time
Onsite
Mid Level
$90K/yr - $120K/yrAnika is a company focused on providing support for manufacturing commercial products. The Quality Engineer II role involves reviewing and approving Process Change Controls, CAPAs, and Deviations, while also supporting new product development and conducting internal audits to ensure high-level product quality and compliance with regulatory requirements.
BiotechnologyHealth CareManufacturingTherapeutics
Responsibilities
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
Qualification
Required
Bachelor's Degree in engineering or equivalent experience
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
Strong writing and presentation skills
Preferred
Working knowledge of Six Sigma a plus
Benefits
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
Company
Anika
Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care.
Founded in 1992
201-500 employees
H1B Sponsorship
Anika has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
Caligan Partners
2024-03-07Post Ipo Equity
1993-05-14IPO
Leadership Team
Cheryl Blanchard
President and CEO
Recent News
2025-11-07
Company data provided by crunchbase