Michael Page
Quality Assurance Engineer
Michael Page, Elgin, Illinois, us, 60122
Unique medical device opportunityCome in and make an impact instantlyAbout Our Client
Our client, a rapidly growing medical device manufacturer is seeking a Quality Assurance Engineer to join their expanding Quality team. They collaborate with well-known OEMs. In this role, you will handle customer communication, lead root cause and corrective actions, and drive initiatives to improve shop floor efficiency. With an innovative product line making a significant impact in the industry, this is an exciting opportunity to be part of a dynamic growing organization.
Job Description
Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.Leads and implements various product and process improvement methodologies.Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.Leads in the completion and maintenance of risk analysis.Leads generation and completion of protocols and reports for test method validations.Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
Relevant Quality Assurance Engineering ExperienceBachelor's Degree (Science Related)3+ years of experience in a Cleanroom environmentStrong Medical Device Manufacturing ExperienceGood knowledge of statistical tool sand appropriate use of Design of Experiments (DOE) when developing recommendationsExcellent communication and interpersonal skillsWorking knowledge of FDA, EU MDR, ISO 13485:2015, 21 CFR and cGMPsWhat's on Offer
Competitive base salary between $80,000-$950,000, depending on experience and skillsBonus opportunity up to 5%Comprehensive benefits package including Medical, Dental and VisionLife and AD&D CoverageShort-term disability coverage15 PTO Days + 10 holidays401(k) with 6% company match
Contact
Max Sinton
Quote job ref
JN-102024-6571526
Our client, a rapidly growing medical device manufacturer is seeking a Quality Assurance Engineer to join their expanding Quality team. They collaborate with well-known OEMs. In this role, you will handle customer communication, lead root cause and corrective actions, and drive initiatives to improve shop floor efficiency. With an innovative product line making a significant impact in the industry, this is an exciting opportunity to be part of a dynamic growing organization.
Job Description
Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.Leads and implements various product and process improvement methodologies.Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.Leads in the completion and maintenance of risk analysis.Leads generation and completion of protocols and reports for test method validations.Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
Relevant Quality Assurance Engineering ExperienceBachelor's Degree (Science Related)3+ years of experience in a Cleanroom environmentStrong Medical Device Manufacturing ExperienceGood knowledge of statistical tool sand appropriate use of Design of Experiments (DOE) when developing recommendationsExcellent communication and interpersonal skillsWorking knowledge of FDA, EU MDR, ISO 13485:2015, 21 CFR and cGMPsWhat's on Offer
Competitive base salary between $80,000-$950,000, depending on experience and skillsBonus opportunity up to 5%Comprehensive benefits package including Medical, Dental and VisionLife and AD&D CoverageShort-term disability coverage15 PTO Days + 10 holidays401(k) with 6% company match
Contact
Max Sinton
Quote job ref
JN-102024-6571526