Job Description
Annual Compensation Range: $75,000-$95,000
Biocoat is committed to providing the best in developing, manufacturing, and applying coatings on medical devices. We are looking for a Quality Engineer to be part of a positive, team-oriented environment.
Biocoat is the proud recipient of the Great Place to Work certification in 2025 for the fourth time!
This role is an on-site position in Horsham, PA.
Responsibilities:
* Oversight of quality systems to meet applicable ISO 13485 and other regulatory requirements, specifically in Design & Development, Validation, Change Control, and Calibration.
* Track, trend, and analyze manufacturing and quality performance to determine actions required for development and continuous improvement.
* Initiate process improvement projects to increase efficiency, reduce costs, simplify processes, and improve quality.
* Provide structure, discipline, and training to ensure manufacturing and quality systems provide repeatable control, are appropriate, adequate, and practiced.
* Conduct and facilitate audits to ensure long-term compliance.
* Conduct and support Nonconformance, CAPA, and Complaint investigations to determine root cause and implement corrective/preventive actions.
* Coordinate and assist with validation activities, including protocol and report review, approval, and execution.
* Participate in and support Internal, Customer, and Regulatory Audits.
* Interface with customers and suppliers to provide technical and quality support.
* Develop and implement methods and standards for sampling, inspection, testing, and evaluation of products.
* Develop and implement statistical methods and design experiments to support process control and improvement.
* Assist in directing technicians engaged in measuring and testing products, and tabulating data concerning products for quality and reliability.
Skills & Requirements:
* Bachelor's degree required; a degree in a Life Science discipline is preferred but not mandatory.
* 3-5 years minimum experience in Quality Assurance or Quality Engineering environment.
* Ability to work proficiently in a regulated manufacturing setting; lab-related experience is a plus.
* Experience with ISO 9001, ISO 13485, or QSR Medical Device manufacturing, and familiarity with QMS documentation and Good Documentation Practices.
* Knowledge of and experience with FDA / ISO medical device regulations.
* Process validation experience and involvement are required.
* Ability to report, evaluate, and interpret scientific data; peer-review as needed.
* Excellent math skills for calculations and test parameters.
* Analytical problem-solving skills; data-driven decision making.
* Proficiency with Microsoft Word, Excel, and Outlook; experience with eQMS and/or ERP systems is highly desired.
* Independent, timely, detail-oriented, and able to follow instructions.
* Strong interpersonal skills and ability to work collaboratively at all levels.
* Flexible team player capable of working in a deadline-driven environment.
* Excellent oral and written communication skills, including technical documentation.
* Organized with the ability to prioritize and follow through on issues and projects.
* Adherence to all safety guidelines and processes, including PPE and gowning requirements.
Work Environment and Physical Requirements:
Office environment with manufacturing and warehouse exposure. Travel less than 5%, including occasional international trips. Must wear PPE and follow safety protocols, especially when working with hazardous chemicals or in cleanroom environments.
What Biocoat Offers:
* Competitive salary and discretionary bonus.
* Comprehensive benefits including medical, dental, vision, and insurance.
* Retirement plan with company match.
* Paid time off, education assistance, rewards program, parental leave, and employee assistance.
* Additional perks like flexible dress code, early Fridays, and company events.
Biocoat is an equal opportunity employer. All qualified applicants will receive consideration without regard to protected characteristics.
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