Role: Quality Engineer (Medical Device)
Location: Minneapolis, MN (Onsite)
We are seeking a highly motivated Quality Engineer with a strong background in the medical device industry to join our team in Minneapolis, MN. This role will ensure compliance with regulatory standards and client requirements while supporting manufacturing, validation, and continuous improvement activities in a fast-paced, regulated environment.
Key Responsibilities:Ensure compliance with applicable medical device regulations, quality standards (FDA, ISO), and client-specific requirements.
Develop, implement, and maintain quality assurance systems and processes to support medical device manufacturing.
Conduct root cause analysis and lead the implementation of corrective and preventive actions (CAPA).
Review and approve design and process changes, validation protocols, and reports to ensure regulatory compliance.
Support and oversee sterilization processes (EtO, steam, gamma) and related validations.
Perform risk assessments (e.g., FMEA) to identify hazards and implement mitigation strategies across the product lifecycle.
Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to maintain high standards of product quality and safety.
Participate in internal and external audits, ensuring timely response and resolution of findings.
Monitor and analyze quality metrics and trends to drive continuous improvement initiatives.
Ensure thorough documentation practices in compliance with GMP, FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
Bachelor's degree in Engineering, Life Sciences, or a related technical field.
5 10 years of experience in quality engineering within the medical device industry.
Strong knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
Experience with sterilization techniques such as EtO, steam, or gamma sterilization is preferred.
Proficient in quality tools and methodologies, including CAPA, FMEA, and statistical analysis.
Excellent problem-solving abilities and high attention to detail.
Strong verbal and written communication skills.
Certification in Quality Engineering (CQE) or similar is a plus.
Hands-on experience with equipment and process validation (IQ, OQ, PQ).
Familiarity with Lean Six Sigma principles and tools.
Knowledge of design control and risk management processes.
On-site or hybrid model based on client requirements.
Must be able to work effectively in a regulated, fast-paced manufacturing environment.
...Job Title ~Web Developer Job Location ~ Pune Seniority Level ~Individual Contributor Range Of Experience ~ 2-4 years Responsibilities: List the responsibilities, these should be the roles KPIs that we would measure on Code quality: Measured via linting...
...Practice Manager Position Description Our client is one of the nations largest and most prestigious physician-owned Orthopedic & Physical Therapy Practice groups with over 60 locations in Maryland, Washington, D.C. & Virginia. The Practice Manager is responsible...
...Maintaining and strengthening positive client relationships throughout the project life is critical. The Director will also support risk management, governance, practice/procedure/tool development, and professional development for the design-build business. Ultimately, the...
...855472 Agency: State Courts System Working Title: COURT PROGRAM SPECIALIST II - 22010983Pay Plan: State Courts System Position... ...division of the court. Candidates must be proficient using computers and Microsoft Office products and able to generate multiple documents...
...an hour Roush has an immediate need for a full-timeCDL A Test Driver. Get paid to test drive prototype trucks and give feedback to... ...responsible for evaluating a variety of CDL license required vehicles. The role will drive vehicles on designated routes and durability...