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