Quality Assurance Engineer - (Capa)

Job Description
At Corza Medical, our mission is to support surgical providers with remarkable service, trusted performance, and outstanding value by creating an unmatched experience that stems from listening to the surgical experts themselves.
Our product family is the result of years of experience championing surgeons and listening to their expertise. We deliver unmatched value across our line of products and offer a seamless, personalized experience designed around surgeons' needs. We're a team of experienced professionals who understand the difference that excellent customer service can make.
We are seeking a QA Engineer. You will be responsible for managing complaint handling system including intake, evaluation, coordination of investigations, maintenance of complaint records, development and presentation of trending reports, and regulatory reporting of device incidents.
What we value

• Integrity. We do what is right.
• Accountability. We do what we say.
• Customer First. We deliver extraordinary experiences.
• One Global Team. We before me, always.
• Inspired. We love what we do.

What you will do

• Support complaint handling system including intake, evaluation, coordination of investigations, maintenance of complaint records, development and presentation of trending reports, and regulatory reporting of device incidents.
• Support ongoing development and maintenance of Risk Management Reports & Assessments (ISO 14971 standard).
• Support ongoing development and maintenance of Clinical Evaluation Reports.
• Support ongoing development and maintenance of Post-Market Surveillance Reports.
• Daily focus on improving, implementing, and maintaining quality system.
• Lead Material Review Board activities ensuring proper trending, closure of issues and dispositions are appropriately addressed. Drive continuous improvement initiatives based on MRB data.
• Support in the development and maintenance of various quality system documents and records, including Device Master Records, Technical Files, QA System Release Records.
• Support QA aspects of design and development of medical devices including compilation, review, and approval of device design history files, risk management reports, coordinate design verification/design validation.
• Assist in the implementation of eQMS system modules as may be assigned.
• Define, develop, and manage various quality projects and validation studies to ensure compliance with global regulatory requirements.
• Manage supplier qualification and supplier oversight programs. Perform external (distributor & supplier) quality assessments as needed.
• Assist in quality system audits and inspections performed by third parties such as EU Notified Body and regulatory authorities, including FDA.
• Support ongoing compliance of internal quality system programs including:
  • Management Review
  • Employee Training
  • Corrective and Preventive Actions
  • Internal quality audits
• Support the generation and maintain documents including; engineering drawings, labeling, IFUs, etc.
• Other duties as assigned.

What you will need

• Minimum of 5-6 years' experience in direct engineering support of quality management systems for medical device & biologics development and manufacturing of sterile devices, (US & EU) class I, II devices and tissue products.
• Solid working knowledge of FDA Quality System Regulation (21 CFR 820) including FDA regulations 21 CFR 801, 803, 807, and 1271), EU Medical Devices Regulation (2017/745) & MEDDEV 2.12-1, ISO 13485, ISO 14971, ISO 11135, ISO 11137.
• Certified Quality Engineer (CQE) is a plus.
• Bachelor's degree in an engineering discipline.
• Experience in process engineering/validation/test method development.
• Excellent organizational and record keeping skills.
• Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative and management personnel.
• Internal and external quality auditing experience is desirable.
• Proficiency in information technology applications such as MS Word, Excel, PowerPoint.
• Proficiency in Solid works CAD Drawing system a plus.

What you will like
We foster a work environment where all team members are empowered and encouraged to share their opinions and ideas. We encourage robust, fact-based debate. Our highly collaborative work environment results in the best decisions for Corza Medical and a shared mission to execute our plan together, on time and on budget.
Join our team
At Corza Medical, we are motivated by enabling our customers' success. That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and service that will ensure the continued success of our company and surgical professionals well into the future.
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.
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