Quality Assurance Specialist

6 days ago


Birmingham, Alabama, United States BioHorizons Full time

About Us

BioHorizons is a renowned medical device company dedicated to delivering innovative solutions for the healthcare industry.

Job Title: Quality Engineer

Location: Birmingham, AL

Estimated Salary:$80,000 - $110,000 per annum

Job Description

We are seeking a highly skilled and experienced Quality Engineer to join our team. As a key member of our quality department, you will play a critical role in ensuring compliance with quality system regulations and standards.

Key Responsibilities:

  • Investigations and Support: Investigate customer product complaints, support investigation teams, and participate in summarizing results.
  • Quality System Management: Establish and maintain minimum policy requirements, controlled documents, and ensure adherence to regulatory standards.
  • Process Validation: Conduct process validations, risk management activities, and support manufacturing and quality efforts.
  • Nonconforming Material Oversight: Manage nonconforming material reports, support the Material Review Board, and ensure proper disposition of products.
  • New Product Development Support: Assist NPD teams with regulatory compliance (21 CFR Part 820, Part 1271) and EU/Canadian standards.
  • Document Control System: Establish, document, conduct, and maintain the company document control system, including change control and record keeping.
  • Research and Development Support: Review and approve design inputs and outputs to support the development process.
  • CAPA Meetings and Actions: Oversee Corrective and Preventive Action meetings and actions.
  • Regulatory and Manufacturing Standard Reviews: Ensure compliance with state-of-the-art standards.
  • Policy and Procedure Updates: Document, release, and communicate changes to supplier quality assurance policies and procedures to stakeholders.

Requirements

To be successful in this role, you must possess excellent reading, writing, and verbal communication skills. Proficiency in Microsoft Windows and Office applications is required. Knowledge of regulatory medical device and international quality standards is desired. You should also have experience working in an FDA-regulated environment and hold a Bachelor's Degree or equivalent combination of experience. ASQ Certified Quality Engineer certification is preferred.

Benefits

We offer a comprehensive benefits package, including two medical plan options, Flexible Spending Account or HSA Account, vision benefits, company-paid dental insurance, wellness plan, 401(k) with 5% matching, generous PTO plan, paid parental leave, casual dress code, and social events for employees and family.



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