Senior Quality Engineer
Precera Medical, Big Lake, MN, United States
Job Description
Position Summary
This position is responsible for leading teams that develop and maintain manufacturing quality plans along with project-specific quality plans, leading efforts related to compiling and analyzing analyze statistical data in order to assess process capabilities and control processes, taking a lead role in investigating and resolving CAPAs, performing internal and external ISO audits, assuring compliance to and providing guidance regarding interpreting governmental regulations and ISO 13485 standards, identifying continuous improvement opportunities, participating on the Material Review Board, preparing required quality documentation and publishing quality metrics.
Key Responsibilities
Lead teams that develop and maintain manufacturing quality plans for the facility, including inspection and control plans, and ensure adherence to and the proper execution those plans.
Lead teams that develop and maintain project-specific quality plans, including establishing quality requirements and standards for projects, while adhering to the customer requirements and working as part of a cross-functional team. Measure and publish project-quality costs.
Lead efforts related to compiling and analyzing statistical data in order to assess process capabilities and control processes and conduct Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&R) and Statistical Process Control (SPC) studies.
Investigate and resolve all assigned Corrective And Preventative Actions (CAPAs), taking a lead role in assuring that all CAPAs are addressed timely.
Perform a lead role and conduct both internal ISO audits and external supplier audits. Participate in the supplier certification process and develop qualification requirements for purchased components and services.
Assure compliance to and provide guidance and expertise regarding interpreting governmental regulations, ISO 13485 standards and internal Quality policies in order to assure compliance.
Identify continuous improvement opportunities and support efforts in order to implement LEAN principles throughout the organization.
Participate on the Material Review Board, assuring the identification of and appropriate disposition of all non-conforming material.
Prepare required quality documentation and reports. Publish and distribute quality metrics.
Other duties as assigned.
Required Qualifications
Bachelor degree in Manufacturing Engineering or related field.
Minimum five years relevant experience.
Equivalent combination of experience in lieu of a degree will be accepted
Experience developing manufacturing quality plans.
Experience conducting process capability, GR&R, PFMEA and SPC studies.
Experience optimizing processes to achieve ongoing cost reductions.
Experience working in an ISO environment, preferably ASO 13485, and conducting internal and supplier audits.
LEAN / Six Sigma training and demonstrated application.
Experience working within a CAPA program.
Demonstrated use of structured problem-solving methods (i.e. 8D).
Proficient PC skills in a Windows environment.
Effective written and verbal communication skills.
Strong interpersonal and teamwork skills.
Preferred Qualifications
Experience in a precision machine shop environment.
Experience using an ERP system.
Compensation and Benefits Overview
Starting Pay Range for this position is $100,000-$115,000/Annually.
Minimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based on various factors, including but not limited to, local labor market conditions, years of relevant experience, education, professional certifications, foreign language proficiency, and other job-specific qualifications.
Employees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life/AD&D insurance, and the company’s 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees.
Full-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time.
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Position Summary
This position is responsible for leading teams that develop and maintain manufacturing quality plans along with project-specific quality plans, leading efforts related to compiling and analyzing analyze statistical data in order to assess process capabilities and control processes, taking a lead role in investigating and resolving CAPAs, performing internal and external ISO audits, assuring compliance to and providing guidance regarding interpreting governmental regulations and ISO 13485 standards, identifying continuous improvement opportunities, participating on the Material Review Board, preparing required quality documentation and publishing quality metrics.
Key Responsibilities
Lead teams that develop and maintain manufacturing quality plans for the facility, including inspection and control plans, and ensure adherence to and the proper execution those plans.
Lead teams that develop and maintain project-specific quality plans, including establishing quality requirements and standards for projects, while adhering to the customer requirements and working as part of a cross-functional team. Measure and publish project-quality costs.
Lead efforts related to compiling and analyzing statistical data in order to assess process capabilities and control processes and conduct Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&R) and Statistical Process Control (SPC) studies.
Investigate and resolve all assigned Corrective And Preventative Actions (CAPAs), taking a lead role in assuring that all CAPAs are addressed timely.
Perform a lead role and conduct both internal ISO audits and external supplier audits. Participate in the supplier certification process and develop qualification requirements for purchased components and services.
Assure compliance to and provide guidance and expertise regarding interpreting governmental regulations, ISO 13485 standards and internal Quality policies in order to assure compliance.
Identify continuous improvement opportunities and support efforts in order to implement LEAN principles throughout the organization.
Participate on the Material Review Board, assuring the identification of and appropriate disposition of all non-conforming material.
Prepare required quality documentation and reports. Publish and distribute quality metrics.
Other duties as assigned.
Required Qualifications
Bachelor degree in Manufacturing Engineering or related field.
Minimum five years relevant experience.
Equivalent combination of experience in lieu of a degree will be accepted
Experience developing manufacturing quality plans.
Experience conducting process capability, GR&R, PFMEA and SPC studies.
Experience optimizing processes to achieve ongoing cost reductions.
Experience working in an ISO environment, preferably ASO 13485, and conducting internal and supplier audits.
LEAN / Six Sigma training and demonstrated application.
Experience working within a CAPA program.
Demonstrated use of structured problem-solving methods (i.e. 8D).
Proficient PC skills in a Windows environment.
Effective written and verbal communication skills.
Strong interpersonal and teamwork skills.
Preferred Qualifications
Experience in a precision machine shop environment.
Experience using an ERP system.
Compensation and Benefits Overview
Starting Pay Range for this position is $100,000-$115,000/Annually.
Minimum pay rates offered will comply with applicable county or city regulations if they exceed the listed range. Actual pay rates are determined based on various factors, including but not limited to, local labor market conditions, years of relevant experience, education, professional certifications, foreign language proficiency, and other job-specific qualifications.
Employees and their families are eligible to participate in a comprehensive benefits package, including company-sponsored medical, dental, vision, flexible spending accounts (FSA), health savings accounts (HSA), voluntary benefits, supplemental life/AD&D insurance, and the company’s 401(k) plan. Additional benefits include access to an employee assistance program (EAP) for employees and household members, long-term disability coverage, and short-term disability for full-time employees.
Full-time and Part-time employees receive Paid Time Off (PTO) based on years of service, as well as paid holidays, personal holidays and MN Safe and Sick Time.
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