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.

MINIMUM QUALIFICATIONS:

Bachelor’s degree in engineering or related field; supplemented by five or more years’ quality engineering experience in a manucturing environment (medical device, aerospace, or automotive preferred); or an equivalent combination of education, certification, training, and/or experience.

KNOWLEDGE, SKILLS, AND ABILITIES:

· 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