Quality Assurance Engineer - Shakopee, United States - KEB America

KEB America Shakopee, United States

4 weeks ago

Show more Collapse job

Description

Job Description

Job DescriptionDescription:

JOB SUMMARY

The Quality Engineer is responsible for coordinating medical device customers' needs and requirements, as well as handling Major Quality Miscue (MQM) forms.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Work closely with customers to address complaints or concerns
Handle customer returns and change requests
Create control plans
Create, update, and modify PFMEAs
Troubleshoot and analyze internal failures
Assist in testing and validation activities
Create and document Major Quality Miscue (MQM) forms
Create corrective action reports
Document and analyze in process failures and rejections (MRB)
Analyze and report production and test system data
Perform random inspections
Create forms, templates, work instructions, or testing procedures
Coordinate with and assist other departments
Follow safety rules and keep clean/orderly work area
Perform other duties as required or assigned

** Job Description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Other duties, responsibilities, and activities may change or be assigned at any time with or without notice. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.**

REPORTING RELATIONSHIP(S):

Reports directly to the Quality Assurance Manager

Requirements:

QUALIFICATION REQUIREMENTS

The requirements listed below are representative of the education, certifications, knowledge, skills, and/or abilities required.

Education / Experience

BS in engineering or similar areas of study

Knowledge, Skills, and Abilities

Moderate knowledge of SAP or ERP systems
Ability to use Microsoft Office to create various documents Basic math skills (standard and metric)
Ability to follow work instructions accurately
Ability to do accurate work at a rapid pace
Ability to communicate clearly and effectively (written and verbal)
Ability to work well independently as well as with others
Have attention to detail
Ability to multi-task
Ability to proficiently read and write in English
Ability to follow all safety rules
Knowledge of KEB products and functions
Basic understanding of inspection equipment (calipers, micrometers, etc.)
Ability to read and interpret blueprints, technical data, instruction manuals, test procedures, etc.
Ability to see and work with small parts with or without accommodation
Ability to think analytically and problem solve
Ability to troubleshoot effectively
Ability to prioritize, balance, and execute several tasks concurrently
Ability to effectively manage one's own time
Ability to exhibit high integrity
Knowledge of SPC
Ability to speak on phone for extended periods of time
Ability to build customer relationships and rapport
Ability to effectively resolve conflicts and maintain composure in stressful situations
Ability to effectively manage one's own time and others

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Majority of time is spent sitting in office environment
Occasional travel to customer sites

WORKING CONDITIONS

The working conditions described here are representative of those an employee may be exposed to while performing job duties and responsibilities.

Office environment
Occasional travel to customer sites

We have other current jobs related to this field that you can find below

Senior Design Assurance Engineer

2 weeks ago

SurModics Eden Prairie, United States

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company's expertise in proprietary surface technologies, alon ...
Design Assurance Engineer

1 week ago

Carrier Minneapolis, United States Full time

About this role · The Product Design Assurance Engineer ensures product design quality and robustness trough the difference phases of a product development process. The Design Assurance Engineer is support the Engineering team in following internal or external process and guideli ...
Senior Design Assurance Engineer

3 weeks ago

SurModics Eden Prairie, United States

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company's expertise in proprietary surface technologies, alon ...
Design Assurance Engineer

1 week ago

Ativa Medical Corporation Saint Paul, United States

Job Description · Job DescriptionDesign Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide su ...
Design Assurance Engineer

1 day ago

Apex Systems, Inc. Maple Grove, United States Part time

Job#: · Job Description: · Design Assurance Engineer · Pay: 40-50/hour (flexible DOE) · About the role: · We have an exciting opportunity for a Senior Design Quality (or Design Assurance) Engineer supporting percutaneous coronary intervention (PCI) single use devices (SUD) with ...
Information Assurance Engineer

1 week ago

General Dynamics Minneapolis, United States

Responsibilities for this Position · Information Assurance Engineer · ID: · USA-MN-Bloomington · Required Clearance: Secret · Posted Date: 2/6/2024 · Category: Security · Employment Type: Full Time · Hiring Company: General Dynamics Mission Systems, Inc. · Basic Qua ...
Information Assurance Engineer

5 days ago

General Dynamics Corporation Minneapolis, United States

Responsibilities for this Position · Information Assurance Engineer · ID: · USA-MN-Bloomington · Required Clearance: · Secret · Posted Date: · 2/6/2024 · Category: · Security · Employment Type: · Full Time · Hiring Company: · General Dynamics Mission Systems, Inc. · Basic Qualifi ...
Senior Design Assurance Engineer

2 weeks ago

Cypress HCM Minneapolis, United States

This Quality Design Assurance Engineer role will focus on design assurance supporting product and process development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality ...
Principal Design Assurance Engineer

1 week ago

Accordance Search Group Plymouth, United States

Our client is an exciting medical technology company searching for a Principal Design Assurance Engineer. In this role you will lead design assurance activities and initiatives supporting Product Development projects including establishing and improving product design requirement ...
Design Assurance Engineer II

1 week ago

Boston Scientific Maple Grove, United States

About the role: · Boston Scientific is currently recruiting for a Design Assurance Engineer II in our Maple Grove MN location. This is an exciting opportunity to participate in development of single use devices for use with medical electrical equipment/systems (MEE) within Inter ...
Design Assurance Engineer I

3 weeks ago

Boston Scientific Maple Grove, United States

About the role: · Apply your skills and experience to ensure patient safety by joining the Design Assurance team at Boston Scientific. Thrive in a culture that prioritizes learning and development, builds lasting relationships with colleagues, and truly makes a difference to pat ...
Senior Quality Assurance Engineer

3 days ago

TLC Millimeter Wave Products, Inc. Minneapolis, United States

Job Description · Job DescriptionBenefits:401(k) · 401(k) matching · Competitive salary · Dental insurance · Free food & snacks · Health insurance · Paid time off · Parental leave · Vision insurance · Wellness resources · Job Title: Senior Quality Assurance Engineer · Department: ...
Senior Engineer, Quality Assurance

6 days ago

Padagis LLC Minneapolis, United States

Padagis LLC is seeking a Senior/Lead Quality Assurance Engineer to provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMN, ensuring that all information and documentation conforms to ...
Associate Quality Assurance Engineer

3 weeks ago

Amano McGann, Inc Saint Paul, United States

Job Description · Job DescriptionTitle/Position: Quality Assurance Engineer · Location: Roseville, MN · Department: Quality Assurance · Employment Type: Full Time · Min. Experience: 5 years · Description · Amano McGann, Inc. (AMI) has an opening for a Quality Assurance Engineer i ...
Senior Design Assurance Engineer

2 weeks ago

Veranex Minneapolis, United States

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data manag ...
Senior Engineer, Quality Assurance

2 weeks ago

Padagis LLC Minneapolis, United States

Padagis LLC is seeking a Senior/Lead Quality Assurance Engineer to provide primary Quality Assurance review and approval for annual product reviews, deviations, and other cGMP documentation and studies conducted at PMN, ensuring that all information and documentation conforms to ...
Design Assurance Engineer II

1 week ago

Abbott Minneapolis, United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
Design Assurance Engineer II

1 week ago

Abbott Laboratories Minneapolis, United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
Senior Design Assurance Engineer

6 days ago

NONIN MEDICAL INC Minneapolis, United States

Job Description · Job DescriptionYou can count on Nonin. Our vision is to improve people's lives by creating noninvasive medical devices people can count on. Nonin's culture is grounded in our mission, and we live by our cultural tenets of courage, ownership, and agility. The cou ...
Senior Design Assurance Engineer

1 week ago

Cypress HCM Saint Paul, United States

Job Description · Job Description Senior Design Assurance Engineer Responsibilities: · • Core Team member of medical device development project teams to ensure compliance to Design Controls requirements. · • Responsible for quality activities and deliverables on the cross-functio ...