Quality Engineer II

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Apex Systems, Inc
Analysis, Development, Excel, Genetic, Hardware, Labeling, Management, Medical Device, Outlook, PowerPoint, Process Engineering, Protocols, Risk Management, Statistical Analysis, Supervision, Testing, Validation
Full Time
Work from home not available Travel not required

Job Description


Job Description

Job #: 1005924
Apex Systems is recruiting on TWO Quality Engineering roles in the Minneapolis area . One would work in Remediation and the other will work on Manufacturing Line Support.

If you are interested in either of the two roles, please reach out to Cassie Miller at cmiller@apexsystems.com


Quality Engineer Remediation
Remediation Quality Engineer

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet company, customer, and regulatory requirements while remediating product line to meet current risk management, equipment qualification, method validation, and process validation requirements.

Responsibilities Will Include:
  • Independently write protocols, execute protocols, write reports around process validations.
  • Support test method validations and equipment qualifications
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Communicate with engineers to support design updates, component qualification, equipment qualification

Quality Systems Duties and Responsibilities:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

What We re Looking For:
Minimum Qualifications
  • BS with 2-5 years of relevant experience
  • Good written and verbal communication skills.
  • Must be able to work independently under limited supervision
  • Knowledge of basic Quality Systems and good documentation practices


Preferred Qualifications
  • Demonstrated experience managing multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines.
  • Experience in medical device field in a manufacturing support role a plus
  • Self-starter with the ability to identify improvement opportunities
  • Experience leading cross-functional teams and driving projects to completion.
  • Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, process engineering
  • Knowledge of analytical techniques and statistical analysis
  • Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate manufacturing performance and issues to peer and senior management audiences.
  • Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
  • Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution System (MES)
  • Bachelor s Degree with engineering or science major



Quality Engineer MFG Line Support
Line Support Quality Engineer

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet company, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.

Responsibilities Will Include:
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.



What We re Looking For:
Minimum Qualifications
  • BS with 2-5 years of relevant experience
  • Good written and verbal communication skills.
  • Must be able to work independently under limited supervision
  • Knowledge of basic Quality Systems and good documentation practices


Preferred Qualifications
  • Demonstrated experience managing multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines.
  • Experience in medical device field in a manufacturing support role a plus
  • Self-starter with the ability to identify improvement opportunities
  • Experience leading cross-functional teams and driving projects to completion.
  • Prior interactions with the following disciplines: manufacturing engineering, post market complaints, CAPA, risk management, supplier quality, process engineering
  • Knowledge of analytical techniques and statistical analysis
  • Comfort speaking to groups of individuals. Presentation skills that comfortably and concisely translate manufacturing performance and issues to peer and senior management audiences.
  • Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook.
  • Familiarity with product/component documentation, inspection and testing, and Manufacturing Execution System (MES)
  • Bachelor s Degree with engineering or science major












EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.

















EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.



Company Information

Apex Systems is a division of the 2nd largest IT staffing and services firm in North America with over 60 branch locations across North America. We help match top IT talent with great companies in all industries. In 2014, Apex placed over 24,500 tech professionals with clients across the U.S. and Canada.
Dice Id : apexsan
Position Id : BHJOB2374_1005924
Originally Posted : 1 month ago

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