About the job Senior Quality Engineer
Senior Quality Engineer - Supplier
Key Responsibilities:
Regulatory & Quality Compliance:
Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulations and standards.
Customer Interface:
Collaborate with contract manufacturing clients to understand and meet their specific quality requirements. Address customer complaints, audit findings, and quality concerns promptly and professionally.
CAPA and Nonconformance Management:
Investigate nonconformances, lead root cause analysis, and implement effective corrective and preventive actions. Maintain accurate records and track CAPA effectiveness.
Process Validation & Qualification:
Lead or support validation activities for equipment, manufacturing processes, and test methods. Prepare and maintain validation documentation to support regulatory requirements.
Quality Documentation:
Author, review, and approve quality-related documents including SOPs, work instructions, protocols, reports, and engineering change orders.
Supplier Quality Support:
Work with Purchasing and Supplier Quality to qualify new suppliers, manage supplier audits, and resolve supplier-related quality issues.
Continuous Improvement:
Identify and drive opportunities for quality and process improvements using Six Sigma, Lean, or other continuous improvement methodologies.
Audit Support:
Assist in the preparation for and execution of internal, customer, and third-party audits. Ensure timely closure of audit findings.
Qualifications:
Bachelors degree in engineering or related field; supplemented by five or more years quality engineering experience in a manufacturing environment (medical device, aerospace, or automotive preferred); or an equivalent combination of education, certification, training, and/or experience.
Required Skills:
- Highly advanced knowledge in the field of engineering and geometric dimensions and tolerances
- Advanced knowledge of measuring tools, including but not be limited to, calipers, micrometers, depth gages, indicators, and plug and tread Go/No Go gages
- Knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job
- Working knowledge of computer software including but not limited to Microsoft Outlook, Excel and Word, Adobe PDF, SolidWorks, in-spec metrology software, internet explorer, Visual Enterprise Resource Planning (ERP) software
- Skilled in basic math including but not limited to adding, subtracting, multiplication, division, geometric construction, practical algebra and metrics for the purpose of calculating material specifications
- Skilled in setting priorities that move projects through efficiently to achieve customer and quality objectives
- Skilled in working independently and following through with assignments with minimal direction
- Ability to read blueprints
- Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
- Ability to learn and adapt to changing technology
- Ability to clearly communicate and understand information in English, both orally and in writing