Here's a short, attractive, and engaging LinkedIn post to promote the Operations Quality Engineer role:
? Elevate Medical Device Quality! ?
We're searching for an experienced Operations Quality Engineer to join a rapidly growing medical device manufacturer. If you're passionate about optimizing QMS, driving compliance (FDA 21 CFR 820, ISO 13485), and working hands-on with cutting-edge products like catheters, this is your chance to make a real impact!
This on-site role in Minneapolis, Minnesota offers significant growth potential, competitive compensation, and a collaborative, fun culture.
Ready to shape the future of healthcare? Learn more & apply here:
#MedicalDevices #QualityEngineer #QMS #Hiring #CareerOpportunity #NowHiring #EngineeringJobs
location: Minneapolis, Minnesota
job type: Permanent
salary: $125,000 - 140,000 per year
work hours: 9am to 5pm
education: Bachelors
responsibilities:
Key Responsibilities:
- Serve as the primary operations quality representative for engineering projects, ensuring compliance with Quality System Regulations throughout product development and changes.
- Lead and participate in investigations for Non-Conforming Material Reports (NCMR) and Corrective and Preventive Actions (CAPA), including troubleshooting manufacturing issues and ensuring compliance. Collaborate with suppliers on quality-related matters.
- Actively participate in cross-functional teams for the review and disposition of nonconforming products or components.
- Contribute to the development and maintenance of Product Risk Management Files, including Risk Management Plans, Assessments, DFMEA, PFMEA, and Risk Management Reports.
- Prepare and rigorously review documentation to ensure accuracy, completeness, and effectiveness.
- Participate in the development of Design Verification and Validation, and Process Verification and Validation test plans and protocols, providing guidance on product requirements compliance.
- Provide expertise and direction for sample size determination and statistical analysis for verification and validation testing.
- Engage in Design Reviews and Failure Mode and Effects Analysis (FMEA) Reviews.
- Participate in complaint investigations, ensuring thorough documentation.
- Provide expert guidance to project teams on all Quality Policies and Procedures, including verification, validation, statistical methods, and design controls.
- Assist with training on Special Work Orders, Receiving Inspection Processes, and First Article Inspections (FAI) as required.
- Engage in routine daily activities such as FAI, CAPA, NCMR, change order review, and training to support overall QMS functions.
qualifications:
Qualifications:
Requirements (Must-Haves):
- Bachelor's degree in Science, Engineering, Technology, or a closely associated field.
- Minimum of 5+ years of experience in Quality Assurance, encompassing quality systems, standards, metrics, and tools.
- Minimum of 5+ years of experience specifically within the medical device industry.
- Working knowledge of medical device regulations, including FDA 21 CFR Part 820 and ISO 13485.
- Working knowledge of new product design and development processes in medical devices.
- Working knowledge of the application of risk management, including Process Failure Mode and Effects Analysis (PFMEA).
- Knowledge of manufacturing operations, process verification and validation, and Geometric Dimensioning & Tolerancing (GD&T), including the ability to read and understand engineering prints and specifications.
- Demonstrated ability to organize and prioritize workflow across multiple projects to meet established timeframes and schedules.
- Experience with catheter-based medical devices.
- Skills in other technical areas such as verification testing and sterilization validation.
- Experience with QMS software systems (e.g., Grand Avenue).
- Strong interpersonal skills for effective cross-functional team collaboration.
skills: Key Skills:
- Quality Management Systems (QMS): Design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, continuous improvement.
- Regulatory Compliance: FDA 21 CFR Part 820, ISO 13485, ISO 14971.
- Documentation: High degree of accuracy, completeness, and effectiveness in preparing and reviewing documentation.
- Technical Proficiency: Design Verification & Validation, Process Verification & Validation, FAI, CAPA, NCMR, Change Order Review, GD&T, manufacturing operations.
- Analytical: Critical thinking, problem-solving, data analysis for quality metrics.
- Collaboration: Cross-functional teamwork, supplier collaboration, communication with design and manufacturing teams.
- Software: Proficiency with QMS software (e.g., Grand Avenue, if applicable), standard office and project management tools.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
