Job Description
Develops and implements methods and procedures for process control, process improvement, testing, and inspection to ensure that products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented, and contributes to supplier quality improvement programs. This is an individual contributor role that requires the use of judgment in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline.
ResponsibilitiesConduct risk assessments, create and analyze risk tables, and develop risk mitigation strategies.Develop and implement quality plans, including Failure Modes and Effects Analysis (FMEA) and control plans.Create, maintain, and update technical documents and procedures.Identify and implement process improvements to enhance product quality and manufacturing efficiency.Ensure compliance with regulatory requirements and industry standards, including ISO and FDA regulations.Collaborate with suppliers to ensure the quality of incoming materials and components.Investigate and resolve non-conformances, and implement corrective and preventive actions (CAPA).Develop and deliver quality training programs for employees.Essential SkillsBachelor’s degree in Engineering, Quality Management, or a related field.Minimum of 3-5 years of experience in quality engineering, preferably in the medical device industry.Strong knowledge of quality management systems, risk management, and regulatory requirements.Excellent problem-solving skills and attention to detail.Effective communication and teamwork skills.Additional Skills & QualificationsCertification in quality engineering (e.g., CQE) is a plus.Work Environment
Work on cutting-edge medical technologies that make a difference in patients’ lives. Opportunities for professional development and career advancement. Be part of a supportive and dynamic team. Comprehensive health benefits, retirement plans, and more.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.