This position is with one of our direct clients. Please submit resumes to pjhala at divihn dot com or call (630) 847 0267 with any questions. Description: The Product Quality Engineer applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products. The Quality Engineer will lead from a technical quality perspective to support product development, design change control and verification/validation activities. This position requires a functional understanding of FDA, ISO and the client Quality systems.
Essential Duties and Responsibilities:
Ensure compliance with global quality systems and regulatory requirements related to product and process Design Control, risk analysis, investigations, and CAPAs
Support the sustainability and life cycle management of an existing product
Perform design change control activities including impact assessments, reviews, and approvals
Provide Quality Assurance support and guidance for verification and validation of product requirements
Support risk management activities as they relate to post-market surveillance
Use statistical trending tools to monitor product complaint trends
Take a lead role in CAPA activities such as investigation, implementation, or verification of effectiveness
Develop and participate in the development of solutions to problems specific to the assigned project
Interact with off-shore suppliers to complete project-related activities
Independently plan, schedule and lead a cross-functional team in detailed phases of the Quality work in a project
Maintain a high level of expertise in current regulatory requirements
Perform other duties as assigned
Qualifications for this Role:
Must have experience or advanced training and demonstrate proficiency in statistical methods
Completely proficient in relevant products or process development processes
Strong interpersonal/communication/influencing/negotiation skills
Good project management skills
Extensive cross-functional team experience, including technical and non-technical work
Ability to diagnose problems and recommend solutions in assigned project
Duties may require work outside regular business hours
Education and Experience
Bachelors of Science degree in Engineering (discipline: electrical/mechanical/biomedical)
4-8 years' recent relevant experience in the medical device industry.
Previous experience working with Electromechanical IV pumps or syringe pumps preferred.
Demonstrated success in delivering results on technical/product/Quality challenges
Experience in design control and strong knowledge of DHF and configuration management
Working knowledge of medical device international standards
Working knowledge of problem-solving and statistical methods as applied to process and product quality preferred
Product development experience pertaining to electromechanical devices preferred
Software: Excel (pivot tables, v-lookups)*, Minitab*, Word, PowerPoint, Trackwise 8 (change control / compliant), and TCU
Local candidates are preferred
Interview Platform: phone followed by onsite interviews (30 minutes each individual interviewer)
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.