Quality Engineer

Eden Prairie, MN - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

This position is responsible for Quality Engineering and assigned aspects of the Quality Assurance (QA) department operations to assure compliance with the Quality System Regulations (QRS) and ISO 13485 requirements. Coordinate feedback of quality indicators and statistics to business team for use in business decisions. Partner with Manufacturing Engineers in process improvements. Perform direct or consult in validations. QA approvals for Engineering Change Notices test methods and test equipment to assure the design and production of medical devices are in compliance with applicable standards. Drive investigations corrective action implementation and corrective action verification activities assigned to business teams.

POSITION RESPONSIBILITIES

Maintain Quality Systems: calibration and preventive maintenance system CAPA suppliers training issues and complaints.
Maintain Monthly metrics and quality objectives
Partners with Mfg. Engineering to assist in developing test methods equipment acquisition for new product testing validations/qualifications statistical analysis of data for significance and other documented requirements for quality objectives.
Identifies applies and updates engineering and technical standards requirements for devices including standards compliance in product design manufacture and labeling.
Participates in the establishment and implementation of quality specifications processes and standards for components process and finished products.
Participates in assigned activities aimed at obtaining and maintaining QSR & ISO compliance.
Performs Receiving Inspection and first articles.
Performs Final Release activities.
Participates in the implementation review and support of non-conforming material control system as assigned. Facilitate the investigation and determination of probable corrective and preventative action for non-conformances.
Support risk analysis effort by following procedures that address hazard analysis failure mode & effects criticality actions and failure analysis.
Support installation qualifications operational qualification performance Qualifications (IQ/OQ/PQ) and Master Validation Quality Plan (MVQP) activities.
Support product returns process.
Support methods/procedures for auditing evaluating and approving suppliers of new materials/components.
Assists in Internal and External Audit activities.
Fosters supplier relations to support supplier selection audits and CAPA issues.
Maintains current knowledge base on existing and emerging regulations standards and guidance documents applicable to the business including interpretation communication of potential impact to the business and assisting in implementing actions to assure compliance.
Participates in the implementation review and support of the customer feedback and complaint system as assigned.
Provide guidance on statistical applications.
Evaluates and approves Document Change Requests (DCRs) for existing products monitor design developments for maintaining quality compliance and assists in software engineering testing and validation.

WORKING CONDITIONS

Light work exerting up to 20lbs. of force or less
Sit or stand at least 8 hours a day
Significant work pace & pressure due to deadlines
Sometimes required to use personal protective equipment

Requirements

Ability to provide technical solutions to a wide range of difficult problems. Solutions are imaginative thorough and practicable and consistent with organizational objectives.
Excellent oral and written communications skills.
Cross-functionally and an effective team player.
Must be able to handle multiple tasks/projects and manage priorities accordingly.
Working knowledge of appropriate industry standards.
Experience in application statistical methods to design reliability and process capability.
Must be able to work in a team environment and exert influence without alienating others.
Working knowledge of statistical analysis/software experience preferred.
Experience in application of statistical methods to design reliability and process capability.
Experience in medical device design and application of test standards.
Minimum two years quality experience with Class II or Class III medical devices.
Bachelor s degree in engineering or life sciences.

POSITION RESPONSIBILITIES

Maintain Quality Systems: calibration and preventive maintenance system CAPA suppliers training issues and complaints.
Maintain Monthly metrics and quality objectives
Partners with Mfg. Engineering to assist in developing test methods equipment acquisition for new product testing validations/qualifications statistical analysis of data for significance and other documented requirements for quality objectives.
Identifies applies and updates engineering and technical standards requirements for devices including standards compliance in product design manufacture and labeling.
Participates in the establishment and implementation of quality specifications processes and standards for components process and finished products.
Participates in assigned activities aimed at obtaining and maintaining QSR & ISO compliance.
Performs Receiving Inspection and first articles.
Performs Final Release activities.
Participates in the implementation review and support of non-conforming material control system as assigned. Facilitate the investigation and determination of probable corrective and preventative action for non-conformances.
Support risk analysis effort by following procedures that address hazard analysis failure mode & effects criticality actions and failure analysis.
Support installation qualifications operational qualification performance Qualifications (IQ/OQ/PQ) and Master Validation Quality Plan (MVQP) activities.
Support product returns process.
Support methods/procedures for auditing evaluating and approving suppliers of new materials/components.
Assists in Internal and External Audit activities.
Fosters supplier relations to support supplier selection audits and CAPA issues.
Maintains current knowledge base on existing and emerging regulations standards and guidance documents applicable to the business including interpretation communication of potential impact to the business and assisting in implementing actions to assure compliance.
Participates in the implementation review and support of the customer feedback and complaint system as assigned.
Provide guidance on statistical applications.
Evaluates and approves Document Change Requests (DCRs) for existing products monitor design developments for maintaining quality compliance and assists in software engineering testing and validation.

WORKING CONDITIONS

Light work exerting up to 20lbs. of force or less
Sit or stand at least 8 hours a day
Significant work pace & pressure due to deadlines
Sometimes required to use personal protective equipment

Requirements

Ability to provide technical solutions to a wide range of difficult problems. Solutions are imaginative thorough and practicable and consistent with organizational objectives.
Excellent oral and written communications skills.
Cross-functionally and an effective team player.
Must be able to handle multiple tasks/projects and manage priorities accordingly.
Working knowledge of appropriate industry standards.
Experience in application statistical methods to design reliability and process capability.
Must be able to work in a team environment and exert influence without alienating others.
Working knowledge of statistical analysis/software experience preferred.
Experience in application of statistical methods to design reliability and process capability.
Experience in medical device design and application of test standards.
Minimum two years quality experience with Class II or Class III medical devices.
Bachelor s degree in engineering or life sciences.