Position: Quality Engineer (Hybrid)

Location: Tempe, AZ

Job Type: Full time with benefits

Company Summary:

TMC is an international high-tech consultancy company that brings expertise to their clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients, and we help them to be more competitive in an ever more global and faster changing technological world.

Job Summary: Develop and implement methodologies for process control, enhancement, testing, and inspection to ensure flawless product functionality. Install and manage advanced testing equipment, perform thorough product assessments to uphold quality standards, and reduce defect rates. Analyze reports and faulty products to identify patterns and recommend corrective actions. Collaborate with suppliers to resolve quality issues promptly and contribute to supplier quality improvement initiatives.

Responsibilities:

• Collaborate with customers, sales/marketing/field personnel, and cross-functional teams to address key quality issues.
• Work with operations and business functions to ensure product and process quality.
• Take ownership and approve NC/CAPA, enhancing problem-solving and root-cause analysis skills.
• Develop and improve manufacturing processes for existing products.
• Review change management activities.
• Maintain KPIs for monitoring process and product quality, analyze trends, and take necessary actions.
• Support the execution and analysis of complaints and product field actions.
• Advocate for Human Factor practices, and develop expertise in Human Factor identification, reduction, and mitigation.
• Understand risk management practices and concepts.
• Optimize inspection methods and sampling.
• Develop proficiency in statistical methods and their application.
• Participate in internal audits and external audit preparations, providing effective narrative and expertise.
• Support manufacturing transfers to other facilities, executing quality activities.
• Initiate and support containment and product holds for potential product escapes.

Qualifications:

• Bachelor's degree in science or engineering (no prior professional experience necessary; previous industry experience preferred).
• Experience with regulatory agencies (FDA, MoH, TUV, etc.) is desired.
• Knowledge of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.
• Familiarity with Quality Concepts such as Risk Management, CAPA, Audits, and Statistics.
• Strong communication, project management, and influencing skills, with the ability to manage multiple tasks simultaneously.
• Ability to represent the Quality function within project teams.
• Excellent interpersonal, written, and oral communication skills, including negotiation abilities.
• Proficiency in critical and creative problem-solving, with strong analytical skills.
• Demonstrated success in managing and completing projects within a matrix organization.
• Ability to work independently and collaboratively within cross-functional teams.

What can you expect from TMC ?

At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.

As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.

Why choose Employeneurship?

We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21st century for high skilled technical professionals. It is built around 5 main pillars:

• You will be a permanent employee given opportunities to support multiple projects.
• You will get the opportunity to receive a share on the profit of your work.
• We will support you with a one-on-one coaching and trainings designed to help you develop your entrepreneurial skills.
• The competence cells within TMC will provide you with a strong, meaningful and relevant network.
• The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups.

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TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.