Job Description: Quality Control (QC) Engineer - Biomedical Devices
Location: Natick, Massachusetts
Employment Type: Full-Time
Experience Level: Mid-Level (2+ years of relevant experience)
About the Role:
We are seeking a skilled and detail-oriented Quality Control (QC) Engineer to join our team in Natick, Massachusetts. The ideal candidate will have experience in quality control processes for FDA-regulated medical devices, particularly in the production of acellular tissue matrix products. This is an exciting opportunity to play a critical role in ensuring the quality and compliance of a product with over 20 years of successful commercial success, impacting lives worldwide.
Key Responsibilities:
Quality Control Operations:
Conduct inspections and quality control tests on raw materials, in-process products, and finished goods to ensure compliance with FDA QMS regulations and ISO 13485 standards.
Develop, document, and maintain QC procedures and protocols.
Regulatory Compliance:
Ensure adherence to quality control standard operating procedures for FDA-regulated medical devices.
Collaborate with the Quality team to maintain alignment with regulatory and company quality standards.
Data Analysis and Reporting:
Analyze test data and prepare detailed reports on product quality, identifying trends, issues, and areas for improvement.
Implement corrective and preventive actions (CAPA) to address quality issues.
Equipment Calibration and Maintenance:
Oversee the calibration, maintenance, and validation of testing and inspection equipment.
Ensure all QC tools and systems operate reliably and comply with industry standards.
Continuous Improvement:
Identify opportunities for process improvements to enhance manufacturing processes and reduce defects.
Audit Support:
Support internal and external audits, including FDA and ISO inspections, by providing documentation and resolving any quality-related findings.
Qualifications:
Education:
Bachelor's degree in Biology, Biotechnology, Biomedical Engineering, Quality Engineering, or a related technical field.
Experience:
Minimum of 5 years of experience in quality control or quality engineering in an FDA-regulated medical device manufacturing environment.
Experience with biologically derived products, such as acellular tissue matrices, is highly desirable.
Technical Expertise:
Knowledge of FDA regulations, GMP, and ISO 13485 standards.
Hands-on experience with quality control tools, techniques, and equipment.
Familiarity with validation processes for 510(k) or PMA devices.
Skills:
Excellent analytical, organizational, and problem-solving skills.
Proficient in statistical analysis and quality control software.
Strong written and verbal communication skills to document and report findings effectively.
Why Join Us?
Join a company that has been a leader in the biomedical field for over two decades. The biomedical devices of the Helios Group of companies have transformed patient care, and we are committed to maintaining its legacy of quality and innovation. We offer a collaborative work environment, professional development opportunities, and competitive benefits.
How to Apply:
Submit your resume and a cover letter highlighting your quality control experience and achievements to careers@helioscardio.com. Please include "Quality Control (QC) Engineer - Biomedical Devices" in the subject line.
We are an equal-opportunity employer and encourage candidates of all backgrounds to apply.