R&D Quality Assurance Engineer
3 weeks ago
Title: R&D Quality Assurance Engineer
Location: North Barrington, IL (*Onsite position)
Some relocation assistance may be available
Due to continuous growth, we are searching for an experienced medical device R&D Quality Assurance Engineer. Within the Medical Murray Engineering team, you will have a hands-on role in product development designing, and producing our clients' medical devices. Our environment will offer a varied day with direct interaction with our clients in discussing assigned projects, next steps, and fielding our clients' questions. Working collaboratively with the Medical Murray team in a high-energy environment, you will work on leading-edge technology as you roll out new medical devices to market. Combining best-in-class design, development, and manufacturing expertise, Medical Murray's purpose is to help healthcare providers offer a higher quality of care, giving patients more time and a higher quality of life. If you want to be part of a team like that, please apply
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.
Position Summary:
The R&D Quality Assurance Engineer 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 that meet the company objectives to provide goods and services that meet customer’s requirements for quality, quantity, and timeliness.
Minimum Qualifications:
- BS or MS in Biomedical or Manufacturing Engineering.
- Quality Engineer Certification desired.
- Green Belt certification desired.
- 3-5 years of experience in quality engineering or R&D engineering for medical devices.
- Strong understanding of ISO standards, FDA regulations, and Quality Systems.
- Experience with design control, establishment of design history files, design verification and validation, and risk management.
- Audit experience strongly preferred.
Knowledge, Skills, Abilities:
- Advanced knowledge and understanding of ISO-13485, ISO-14971, and FDA 21 CFR Part 820 cGMP standards.
- Technical skills must include medical device testing, protocol writing, and report writing.
- Advanced knowledge of statistics, for example, data analysis and SPC.
- Computer skills needed include Microsoft Office or equivalent.
- Strong analytical and problem-solving skills.
- Excellent verbal and written communication skills.
Essential Duties and Responsibilities:
- Understand internal and external quality and regulatory standards and requirements.
- Represent Quality on development teams to ensure compliance with quality management system and applicable regulatory requirements and standards.
- 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.
- Create and maintain Quality Plans for development projects.
- Contribute to risk management activities compliant with ISO 14971.
- Review and provide input to design and manufacturing documentation including material specifications, drawings, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured.
- Develop and optimize quality control inspection documentation, including inspection procedures and forms, and sample sizes based on critical design attributes, risk levels, and statistical rationale.
- Perform inspections on manufactured products, ensuring suitable metrology is used.
- Assist in creating test protocols to then perform and document testing according to those protocols. This includes design verification and validation testing, lot release testing, test method validation, measurement repeatability and reliability, process validation, etc.
- Train technicians and inspectors as needed.
- Participate in report creation.
- Review and approve lot history records and other quality records and project documentation to ensure compliance.
- Contribute to and review nonconformance reports, temporary deviation orders, corrective and preventative action reports, and other quality records.
- Ensure design input / output documentation is complete and compliant, and that design and development activities are compliant with the quality management system.
- Monitor customers’ 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.
- Support the customer complaint process for R&D and evaluate returned product.
- Participate in supplier selection process and defining incoming inspection criteria and sampling requirements.
- Monitor suppliers and quality of materials and services provided.
- Assist in internal and external audits of the quality system.
- Provide general quality support as required by management.
- Demonstrate understanding of D&D process and quality assurance by showing independence by recommending project direction and initiating project tasks to meet deliverables; show ability to lead a project.
- Demonstrate competence of product development by communicating status and recommendations to customers.
- Gain customer satisfaction with communication.
For Your Benefits:
- Competitive salary
- Billable overtime, or can be taken as additional PTO
- Medical Insurance (BCBS): Eligible on the first day of employment
- HSA-eligible health insurance
- Dental Insurance
- Company paid Vision, Life, and Long and Short-Term Disability insurance
- TeleDoc program
- Identity protection
- 401k safe harbor retirement plan
- 18 days of PTO
- Tuition reimbursement
- Paid time off for community outreach and volunteering
Medical Murray is an equal-opportunity employer.
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