What are the responsibilities and job description for the Quality Control (QC) Engineer - Biomedical Devices position at Helios Cardio?
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 :
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.
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.
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.
Oversee the calibration, maintenance, and validation of testing and inspection equipment.
Ensure all QC tools and systems operate reliably and comply with industry standards.
Identify opportunities for process improvements to enhance manufacturing processes and reduce defects.
Support internal and external audits, including FDA and ISO inspections, by providing documentation and resolving any quality-related findings.
Qualifications :Bachelor’s degree in Biology, Biotechnology, Biomedical Engineering, Quality Engineering, or a related technical field.
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.
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)
devices.
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.
