The wage range for this position is $95,000 to $105,000. Compensation decisions are dependent on the specific details and circumstances of each candidate such as experience, skills, and education. Therefore, job title and salary range may vary.
Title: R&D Quality Assurance Engineering Team Lead
Location: North Barrington, IL (Onsite Position)
Some relocation assistance may be available

Position Summary:

Reporting to the Director of Quality Assurance & Regulatory Affairs, The R&D Quality Assurance Engineering Team Lead position works within the Quality Department to support development projects and contribute to R&D efforts from concept to production for disposable medical devices including catheters, catheter-based delivery systems, and other disposable devices for disciplines ranging from cardiology and neurology to urology. This position will work with high performance cross-functional teams to develop products which meet the company objectives to provide goods and services that meet customer’s requirements for quality, quantity, and timeliness. The Team Lead supervises the R&D quality engineers at their site and assigns work.

Essential Duties and Responsibilities:

• Provide guidance and training to employees on internal and external quality and regulatory standards and requirements
• Partner with R&D to determine and implement design controls based on risk management, customer needs and requirements, and manufacturability considerations
• Develop and update Design History Files on behalf of the customers
• Ensure design input / output documentation is complete and compliant, and that design and development activities are compliant with the quality management system
• Create and maintain Quality Plans for development projects
• Contribute to risk management activities compliant with ISO 14971
• Manage and assist with verification and validation activities and documentation
• Plan and document studies of measurement repeatability and reproducibility and process capabilities
• Develop and optimize quality control inspection procedures and sample sizes based on critical design attributes, risk levels and statistical rationale. Ensure suitable metrology is used
• Oversee and perform testing and inspection activities, including training of inspectors or technicians
• Monitor customer’s regulatory submission questions, compliance questions, audit results, and proactively communicate lessons learned internally. Assist in writing responses for product and quality system-related questions
• Apply systematic problem-solving methodologies in identifying, analyzing, prioritizing, communicating, and resolving quality issues, including root cause investigations
• Manage the customer complaint process for R&D and evaluate returned product
• Monitor, evaluate, and qualify suppliers and quality of materials and services provided
• Review documents and quality records in R&D for quality compliance
• Assist in maintaining, implementing, and updating the Quality Management System
• Perform internal audits of the quality system and represent the company in external audits
• Supervise the R&D Quality Engineers, including managing training and appraisals and assigning work
• Manage selection and hiring of personnel, in accordance with company policies with support from the department Director
• Oversee employee performance including disciplinary action (discipline in conjunction with HR)
• Support team in resolving project issues and customer escalations
• Provide general quality support as required by management

Minimum Qualifications:

• BS in an engineering discipline or equivalent experience
• Proven leader that can embrace and promote change in a dynamic environment
• Ability to lead a group and promote employee engagement and proper deployment on projects
• Medical device quality experience is mandatory to participate in complex development projects
• Six Sigma Black belt desired
• Quality assessment/audit experience
• 5 or more years of experience in Quality Engineering for medical devices, including new product development preferred
• Experience in the area(s) of ISO and FDA Quality Systems
• Experience in employee supervision preferred
• Experience with design control and establishment of design history files

Knowledge, Skills, Abilities:

• Knowledge and understanding of ISO-13485, ISO-14971, and FDA 21 CFR Part 820 cGMP standards
• Technical skills must include disposable medical device testing, protocols, analysis, and report writing
• Knowledge of statistics, for example, experiment design and SPC
• Computer skills needed include Microsoft Office or equivalent
• Strong analytical and problem-solving skills
• Well organized, flexible, self-starter, team motivated, and excellent at prioritizing and multi-tasking
• Ability to manage time and self to meet organizational objectives
• Excellent verbal and written communication skills

For Your Benefits:

• Competitive salary
• Medical insurance (BCBS): Eligible on first day of employment
• HSA-eligible medical plans
• Dental insurance
• Company-paid employee vision, Life, and Long and Short-Term Disability insurance
• 401k safe harbor retirement plan (3% employer contribution annually)
• 18 days of Paid Time Off
• Option of PTO or straight-time pay for overtime hours worked
• Voluntary Life
• TeleDoc program
• Identity protection
• Tuition Reimbursement
• Paid time off for community outreach and volunteering

About Medical Murray:

Since 1996, Medical Murray has been a privately owned company producing finished medical devices, components, and subassemblies for customers around the world ranging from startups to the largest OEMs. We specialize in the development, testing, and manufacturing of permanent implants, delivery systems, and complex catheters for vascular, gastrointestinal, urologic, and other interventional markets. Our core goals are Integrity First, People Matter, First Class Service, Inspired Innovation, and Community Service. To learn more, please visit us at www.medicalmurray.com

Medical Murray is an equal-opportunity employer