Quality Engineer

2 weeks ago

Minneapolis, United States Integer Holdings Corporation Full time

By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.

At Integer, our values are embedded in everything we do.

Customer

We focus on our customers' success

Innovation

We create better solutions

Collaboration

We create success together

Inclusion

We always interact with others respectfully

Candor

We are open and honest with one another

Integrity

We do the right things and do things right

Job Summary:

  • The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing/operations in accordance with applicable Regulatory and Standards requirements for compliance. Provide work direction for 3-5 Technicians/Inspectors.

Key Accountabilities and Responsibilities

  • Adheres to GB Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
  • 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.
  • Effectively communicate and interact with customers.
  • Leads and manage complaint investigations.
  • Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
  • Assists with product transfers.
  • Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
  • Provides support to other quality engineers.
  • Performs other functions as required.

Job Requirements

  • Minimum Education: Bachelor's degree in engineering or related field required. Minimum Experience: 5-7 years' experience in medical device or regulated manufacturing
  • Specialized Knowledge: Competence in the selection and use of Quality Engineering Tools and Techniques. Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in Microsoft Office and Minitab
  • Ability to work independently and in team environment.
  • Ability to effectively communicate written and verbally.
  • Ability to manage time effectively to ensure timely completion of tasks.
  • Knowledge of SPC, FMEA, DOE, RCA, GDT Sound knowledge of quality management systems.

U.S. Applicants: EOE/AA Disability/Veteran

  • Quality Engineer

    2 weeks ago

    Minneapolis, United States Banner Engineering Full time

    Why Work at Banner?For over 50 years, Banner Engineering has been at the forefront of some of the biggest industry trends, such as the Industrial Internet of Things (IIoT), and our photoelectric, ultrasonic, and vision sensors, LED lights and indicators, monitoring solutions, and other safety products are used by Fortune 500 companies and industry leaders...

  • Quality Engineer

    3 days ago

    Minneapolis, United States Banner Engineering Full time

    Why Work at Banner? For over 50 years, Banner Engineering has been at the forefront of some of the biggest industry trends, such as the Industrial Internet of Things (IIoT), and our photoelectric, ultrasonic, and vision sensors, LED lights and indicators, monitoring solutions, and other safety products are used by Fortune 500 companies and industry leaders...

  • Senior Quality Engineer

    7 days ago

    Minneapolis, United States Olympus Full time

    The Product Quality Engineer is responsible for the design, development and management of projects for legacy products. The Product Quality Engineer provides organizational support with a focus on Design Quality activities. Works with internal/extern Quality Engineer, Quality, Engineer, Product Development, Manufacturing Engineer, Senior, Technology

  • Quality Engineer

    1 week ago

    Minneapolis, United States Wagner Spray Tech Full time

    Job Description Job Description Position Objective: Assure Wagner Spray Tech products conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. Through active participation and involvement, lead efforts to support supplier development creating process and procedures, drive metrics and digital...

  • Quality Engineer

    2 weeks ago

    Minneapolis, United States Wagner Spray Tech Full time

    Job DescriptionJob DescriptionPosition Objective: Assure Wagner Spray Tech products conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner.  Through active participation and involvement, lead efforts to support supplier development creating process and procedures, drive metrics and digital...

  • Quality Engineer

    1 week ago

    Minneapolis, United States Wagner Spray Tech Full time

    Position Objective: Assure Wagner Spray Tech manufactured materials conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. Through active participation, support new product development and sustaining engineering activities in a manner that results in product designs that meet user expectations....

  • Quality Engineer

    4 weeks ago

    Minneapolis, United States PSG Global Solutions Full time

    Description We're looking for a Quality Engineer , working in Biotechnology/Medical Devices industry in 7611 Northland Drive North, Minneapolis, Minnesota, 55428, United States . Responsibilities: Executes and participates in FMEA/Risk Management activities. Serves as a technical resource for problem investigations to guide root cause analysis and corrective...

  • Manufacturing Quality Engineer

    3 weeks ago

    Minneapolis, United States Cypress HCM Full time

    A cutting-edge medical parts manufacturer in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will ideally come from Swiss Machining or Thermoplastics and will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and...

  • Quality Engineer Clojure

    2 days ago

    Minneapolis, United States Wipro Full time

    Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients most complex digital transformation needs. We leverage our holistic portfolio of Quality Engineer, Engineer, Technology, Experience, Quality

  • Senior Quality Engineer

    4 days ago

    Minneapolis, United States Integer Holdings Corporation Full time

    The primary purpose of this position is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. You will ensure that Integer internal and external customers’ expectations are met or exceeded. Is this your next job Read the full description below to find out, and do not hesitate...

  • Senior Quality Engineer

    1 month ago

    Minneapolis, United States Integer Holdings Corporation Full time

    The primary purpose of this position is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. You will ensure that Integer internal and external customers’ expectations are met or exceeded. Adheres to Integer Core Beliefs and all safety and quality requirements including, but...

  • Senior Quality Engineer

    1 month ago

    Minneapolis, United States Integer Holdings Corporation Full time

    The primary purpose of this position is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. You will ensure that Integer internal and external customers’ expectations are met or exceeded. Adheres to Integer Core Beliefs and all safety and quality requirements including, but...

  • Senior Quality Engineer

    1 month ago

    Minneapolis, United States Integer Holdings Corporation Full time

    The primary purpose of this position is to apply intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. You will ensure that Integer internal and external customers’ expectations are met or exceeded. Adheres to Integer Core Beliefs and all safety and quality requirements including, but...

  • Senior Quality Engineer

    6 days ago

    Minneapolis, United States Integer Holdings Corporation Full time

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success...

  • Senior Quality Engineer

    1 month ago

    Minneapolis, United States Integer Holdings Full time

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. At Integer, our values are embedded in everything we do. Customer We focus on our customers' success Innovation We create better solutions Collaboration We create success...

  • Quality Engineer

    2 days ago

    Minneapolis, United States Medix Full time

    Summary Statement: Join our dynamic team and play a pivotal role in ensuring the compliance of our Quality Management System (QMS). We're seeking a dedicated individual to collaborate closely with our small team, ensuring adherence to regulatory standards and maintaining the highest quality standards on-site, full-time. This role is crucial in upholding the...

  • Quality Engineer

    2 weeks ago

    Minneapolis, United States Medix Full time

    Summary Statement: Join our dynamic team and play a pivotal role in ensuring the compliance of our Quality Management System (QMS). We're seeking a dedicated individual to collaborate closely with our small team, ensuring adherence to regulatory standards and maintaining the highest quality standards on-site, full-time. This role is crucial in upholding the...

  • Quality Systems Engineer

    3 days ago

    Minneapolis, United States EPM Scientific Full time

    Summary: As the Quality Systems Engineer, you will ensure the implementation, maintenance, monitoring, and reporting of designated quality system processes to ensure their sufficiency and continual enhancement in an ISO13485 environment. With a primary focus on nonconformance and Corrective and Preventive Action (CAPA) quality systems, this role spearheads...

  • Engineer, Principal Quality Assurance

    7 days ago

    Minneapolis, United States Olympus Full time

    Develop, maintain, and support the company Quality System, regulatory requirements and business strategy. Continuously improve Quality performance related to New Product Development, procurement, manufacturing, and metrics related to the strength of Quality Assurance, Assurance, Engineer, Quality Engineer, Principal, Quality, Technology

  • Quality Systems Engineer

    2 weeks ago

    Minneapolis, United States EPM Scientific Full time

    Summary: As the Quality Systems Engineer, you will ensure the implementation, maintenance, monitoring, and reporting of designated quality system processes to ensure their sufficiency and continual enhancement in an ISO13485 environment. With a primary focus on nonconformance and Corrective and Preventive Action (CAPA) quality systems, this role spearheads...