Quality Engineer

ZipRecruiter; Horsham; On-site; USD 75,000 - 95,000; Full time

Job summary

A leading company in medical device coatings is seeking a Quality Engineer for their Horsham location. The role involves ensuring compliance with quality systems, conducting audits, and driving process improvements. The ideal candidate will have a Bachelor's degree and experience in Quality Assurance or Engineering, with a focus on ISO regulations. The position offers a competitive salary and comprehensive benefits, including paid time off and retirement plans.

Benefits

Comprehensive benefits including medical, dental, vision

Retirement plan with company match

Paid time off

Education assistance

Flexible dress code

Qualifications

• 3-5 years minimum experience in Quality Assurance or Quality Engineering.
• Experience with ISO 9001, ISO 13485, or QSR Medical Device manufacturing.

Responsibilities

• Oversight of quality systems to meet ISO 13485 and regulatory requirements.
• Track and analyze manufacturing and quality performance for improvement.
• Conduct audits to ensure compliance.

Skills

Analytical problem-solving

Excellent oral and written communication

Interpersonal skills

Detail-oriented

Education

Bachelor's degree

Life Science discipline

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

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.