Viant Medical
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Sr. Quality Engineer - Manufacturing
role at
Viant Medical 1 day ago Be among the first 25 applicants Join to apply for the
Sr. Quality Engineer - Manufacturing
role at
Viant Medical Get AI-powered advice on this job and more exclusive features. Quality Assurance - Sr. Quality Engineer - Manufacturing
We are seeking a highly experienced and motivated Senior Quality Engineer to join our team. This role is critical in ensuring product quality and regulatory compliance throughout the design and manufacturing process. The ideal candidate will bring deep expertise in quality systems, process improvement, and cross-functional collaboration within a regulated industry, preferably medical devices.
Benefits:
Medical, Dental, and Vision benefits, effective date of hire 136 Hours PTO (prorated based on hire date) & 10 paid Holidays Company-paid life insurance 401k plan
Key Responsibilities
Adhere to company Core Beliefs and all safety and quality requirements, including, but not limited to company Quality Management System (QMS); Environmental, Health & Safety; company policies, procedures, and work instructions; and other relevant regulatory requirements. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Monitor manufacturing of assigned products, ensuring compliance with DMR and quality system requirements, and ensure complete and correct Device History Records are maintained. Identify, prioritize, and implement product and process improvement initiatives. Review the adequacy and correctness of changes to Bills of Material (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. Generate and lead the completion of protocols and reports for product, process, and test method validations. Partner with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where required and/or appropriate. Develop various inspection techniques and procedures to ensure product integrity to design specifications. Write and implement Incoming, In-Process, and Final Inspection procedures. Ensure that the disposition of non-conforming materials comply with all relevant requirements and ensure that appropriate corrective actions are implemented to prevent recurrence. Lead complaint investigations and manage appropriate remediation activities. Review quality data for potential CAPA’s, including analyses of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analyses. Assist with product transfers. Work with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems. Also, assist each of these groups with capability studies and the application of statistical quality control, including Cpk, DOE, Hypothesis Testing, etc. Provide technical support and direct the work of Quality Inspectors, Quality Technicians, Training Specialists, and/or other Quality Engineers as needed.
Qualifications
Education:
Bachelor’s degree in Engineering (Mechanical Engineering preferred) or a related discipline.
Experience:
Minimum 7+ years of Quality Assurance experience in a regulated manufacturing environment, preferably medical devices or other regulated industry.
Certifications (Preferred):
CQE, CRE, CQA, Six Sigma Green or Black Belt
Skills & Competencies
Strong knowledge of root cause analysis, DOE, statistics, lean manufacturing, risk management, and Six Sigma methodologies. Proficient in Microsoft Office and Minitab. Familiarity with metals processing and Toyota Production System is a plus. Excellent interpersonal, written, and verbal communication skills. Proven ability to work independently and manage multiple priorities. Demonstrated success in driving continuous improvement and leading cross-functional teams.
We offer market competitive compensation. Potential salary range for this role is $90k-$110k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Part-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Viant Medical by 2x Get notified about new Senior Quality Engineer jobs in
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Sr. Quality Engineer - Manufacturing
role at
Viant Medical 1 day ago Be among the first 25 applicants Join to apply for the
Sr. Quality Engineer - Manufacturing
role at
Viant Medical Get AI-powered advice on this job and more exclusive features. Quality Assurance - Sr. Quality Engineer - Manufacturing
We are seeking a highly experienced and motivated Senior Quality Engineer to join our team. This role is critical in ensuring product quality and regulatory compliance throughout the design and manufacturing process. The ideal candidate will bring deep expertise in quality systems, process improvement, and cross-functional collaboration within a regulated industry, preferably medical devices.
Benefits:
Medical, Dental, and Vision benefits, effective date of hire 136 Hours PTO (prorated based on hire date) & 10 paid Holidays Company-paid life insurance 401k plan
Key Responsibilities
Adhere to company Core Beliefs and all safety and quality requirements, including, but not limited to company Quality Management System (QMS); Environmental, Health & Safety; company policies, procedures, and work instructions; and other relevant regulatory requirements. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality. Monitor manufacturing of assigned products, ensuring compliance with DMR and quality system requirements, and ensure complete and correct Device History Records are maintained. Identify, prioritize, and implement product and process improvement initiatives. Review the adequacy and correctness of changes to Bills of Material (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc. Generate and lead the completion of protocols and reports for product, process, and test method validations. Partner with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where required and/or appropriate. Develop various inspection techniques and procedures to ensure product integrity to design specifications. Write and implement Incoming, In-Process, and Final Inspection procedures. Ensure that the disposition of non-conforming materials comply with all relevant requirements and ensure that appropriate corrective actions are implemented to prevent recurrence. Lead complaint investigations and manage appropriate remediation activities. Review quality data for potential CAPA’s, including analyses of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analyses. Assist with product transfers. Work with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems. Also, assist each of these groups with capability studies and the application of statistical quality control, including Cpk, DOE, Hypothesis Testing, etc. Provide technical support and direct the work of Quality Inspectors, Quality Technicians, Training Specialists, and/or other Quality Engineers as needed.
Qualifications
Education:
Bachelor’s degree in Engineering (Mechanical Engineering preferred) or a related discipline.
Experience:
Minimum 7+ years of Quality Assurance experience in a regulated manufacturing environment, preferably medical devices or other regulated industry.
Certifications (Preferred):
CQE, CRE, CQA, Six Sigma Green or Black Belt
Skills & Competencies
Strong knowledge of root cause analysis, DOE, statistics, lean manufacturing, risk management, and Six Sigma methodologies. Proficient in Microsoft Office and Minitab. Familiarity with metals processing and Toyota Production System is a plus. Excellent interpersonal, written, and verbal communication skills. Proven ability to work independently and manage multiple priorities. Demonstrated success in driving continuous improvement and leading cross-functional teams.
We offer market competitive compensation. Potential salary range for this role is $90k-$110k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Part-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Viant Medical by 2x Get notified about new Senior Quality Engineer jobs in
Wheeling, IL . Mundelein, IL $75,000.00-$90,000.00 9 hours ago Senior Mechanical Engineer IV - Communications
Carpentersville, IL $95,000.00-$115,000.00 4 days ago Senior Structural Engineer - Technical Manager
Chicago, IL $118,955.00-$187,350.00 1 week ago Northbrook, IL $78,767.00-$145,719.00 4 weeks ago Chicago, IL $125,000.00-$175,000.00 2 weeks ago Quality Mechanical Engineer/ Inspector @ Chicago, IL (1099 Contractor)
Chicago, IL $75,000.00-$90,000.00 2 weeks ago Chicago, IL $110,000.00-$150,000.00 1 day ago Software Quality Assurance Test Engineer
Chicago, IL $80,000.00-$110,000.00 2 weeks ago Elgin, IL $105,000.00-$115,000.00 1 week ago Chicago, IL $105,400.00-$136,400.00 3 weeks ago Senior Quality Engineer - Communications
Carpentersville, IL $95,000.00-$110,000.00 2 weeks ago Bloomingdale, IL $90,000.00-$115,000.00 1 week ago Villa Park, IL $100,800.00-$138,600.00 18 hours ago Senior Air Quality Engineer/Specialist - Environmental Services (Chicago)
Chicago, IL $130,000.00-$175,000.00 3 weeks ago Electrical Engineer - Mission Critical Facilities
Chicago, IL $75,100.00-$119,800.00 2 months ago Senior Quality Assurance Quality Control Engineer
Niles, IL $70,873.42-$85,352.94 4 weeks ago Engineering & Quality - Software Engineer, Associate Director
Chicago, IL $140,000.00-$150,000.00 1 week ago Chicago, IL $85,580.00-$113,451.80 1 week ago Greater Chicago Area $90,000.00-$140,000.00 5 months ago Round Lake Beach, IL $86,500.00-$135,960.00 6 days ago Oak Brook, IL $81,500.00-$155,225.00 2 weeks ago Chicago, IL $90,000.00-$130,000.00 4 days ago Oakbrook Terrace, IL $100,800.00-$138,600.00 18 hours ago Deerfield, IL $79,300.00-$127,000.00 1 month ago North Chicago, IL $82,500.00-$157,500.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr