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Acara Solutions Quality Engineer in Buffalo, New York

Acara Solutions in downtown Buffalo, NY is seeking a Medical Manufacturing Quality Engineer.
Our team consists of next generation partnerships of clinicians, researchers, industry, and entrepreneurs. Our vision is that our medical innovations improve healthcare outcomes and result in economic development in Western New York.

Role Summary:
The Quality Engineer ensures that our processes, services, and product designs meet client, industry, and regulatory requirements per ISO 13485:2016 and 21 CFR 820. These provide quality assurance to our clients, while fostering medical device innovation.

Importance?
As a Quality Engineer here, you ensure that our systems and products meet client and regulatory requirements, providing clients with peace of mind when working with us. This allows us to create product designs and experiences that genuinely impact people’s lives. You’ll be part of strengthening the medical device innovation backbone.

Once you are here you might:
• Apply quality and project management principles throughout design controls and manufacturing processes.
• Lead Quality activities in product and process design, including risk management such as hazard analyses, design and usability FMEAs, and reports.
• Lead Quality activities in product manufacturing, including root cause analysis of identified issues, corrective and preventive actions, non-conformances, customer complaints, audits, process monitoring, and improvements.
• Ensure compliance of all practices to the quality system, ISO 13485:2016 and 21 CFR 820 requirements.
• Identify and communicate opportunities for and execute the training of others within the organization and manage associated records.
• Prepare annual quality system management review materials.
• Prepare for and perform annual internal audit activities.
• Manage, communicate, and solicit customer feedback according to requirements within the quality system.
• Manage the organization’s control documents and engineering change control systems.
• Manage the organization’s equipment listing, develop internal calibration procedures, and coordinate preventative maintenance and calibration activities.
• Manage and develop/ execute equipment software and process validations.
• Prepare and communicate monthly monitoring of quality objectives.
• Manage external suppliers, including supplier qualification, performance monitoring, evaluation, and auditing.
• Use appropriate statistical and Quality measurement tools, such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, micrometers/calipers, applying data distributions, identifying relationships between variables, design and analyses of experiments with statistical decision making.
• Support regulatory submission and reporting activities.
• Prepare communications in weekly reports, status updates, detailing progress and costs for management.
• Apply critical thinking skills to all tasks and offer solutions to improve processes.
• Collaborate with engineers, physicians, scientists, and researchers.
We are a Team of Innovative thinkers and flexible to consider part-time to full-time hours/schedules.
Your future starts here:
Email your resume to: kruzickia@acarasolutions.com

Required Skills / Qualifications:
1) Bachelor's degree in an Engineering or Science field
2) At least 3 years of practical experience in the neurovascular, cardiovascular, or related medical device industry or 3+ years’ experience in industry, plus advanced degree.
3) At least one year Advanced understanding of FDA requirements associated with the development of medical devices (e.g. ISO 13485:2016, 21 CFR 820)
4) At least 1 year Advanced understanding of Statistical Methods and Project Management Principles
5) At least 1 year Quality activities in product and process design, including risk management such as hazard analyses, design and usability FMEAs, and reports.
6) At least 1 year Quality activities in product manufacturing, including root cause analysis of identified issues, corrective and preventive actions, non-conformances, customer complaints, audits, and process monitoring and improvement.

Preferred Skills / Qualifications:
1) Master's degree in an Engineering or Science field preferred
2) Design History Files, Regulatory Strategy - formal training preferred
3) Must perform well individually and in cross-functional, highly dynamic development teams.
4) Ability to work in fast paced organization, meeting multiple deadlines, and succeeding under pressure.
Additional job duties:
• Interact with engineers, physicians, scientists, and researchers.
• Improve/support existing processes.
• Other tasks as assigned by management.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron?s strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.

Aleron companies; Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, Viaduct, and Aleron's strategic partner, SDI are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.

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