Contractor Quality Engineer w/ ISO13485 and medical experience

Summary of Responsibilities

Job Title: Contract Quality Engineer

Location: Noblesville, INShift: Day Shift (Minimal weekend work and overtime)Duration: 6-8 Months ProjectHours: Minimum 40 hours per week

Pay Rate: $50ph

Position Summary:We are seeking a skilled and detail-oriented Contract Quality Engineer to join our team in Noblesville, IN. This position will play a critical role in ensuring quality assurance processes, regulatory compliance, and continuous improvement within our organization. The successful candidate will work closely with cross-functional teams, utilizing their expertise in quality engineering, problem-solving, and project management to support our goals and ensure product excellence.

This role will be a contractor position on behalf of Stratosphere Quality, supporting our client/customer.

Essential Job Function

Key Responsibilities:

• Provide general quality assurance support across systems, processes, and products.
• Perform root cause analysis and implement corrective actions to resolve quality-related issues.
• Collaborate with teams to plan and execute process improvements.
• Conduct testing, data analysis, and validation activities to ensure product compliance.
• Manage document control, prepare reports, and maintain accurate records.
• Audit systems, processes, and products to ensure adherence to regulatory and quality standards.
• Lead and support project management efforts, ensuring clear and professional communication with stakeholders.

Qualifications

Qualifications and Skills:

• Knowledge or familiarity with regulatory standards, particularly in the medical device industry (ISO 13485).
• Working knowledge of ISO 13485 and its application in quality systems.
• General Quality Engineering skills, including blueprint reading, gauging, and tooling knowledge.
• Understanding of product assembly, material flow, and material control processes.
• Experience in quality planning, validation, and development activities.
• Strong attention to detail and excellent analytical, critical thinking, and problem-solving skills.
• Proficient in Microsoft Office Suite, SharePoint, and quality assurance software.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.