Quality Engineer III

6 days ago


Salem, 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

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.
  • Adheres to Integer's 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.

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

Specialized Skills:

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



  • Salem, United States ACL Digital Full time

    The Office of Information Services (OIS) is a shared service provider for the Oregon Health Authority (OHA) and Oregon Client (ODHS). OIS provides the technology systems and services that support more than 18,000 OHA and ODHS agency staff at local offices and facilities around the state. These systems and services help the two agencies determine client...

  • Quality Engineer

    1 month ago


    Salem, United States ASSA ABLOY Full time

    Career Opportunities: Quality Engineer (29753) Requisition ID 29753 - Posted - Assa Abloy High Security Group, Inc. - Architectural Hardware Group - USA: Virginia (Salem) - Quality Management - Posting Country (1) - Yes - Mid-senior level - Travel Required: 0%-10%  Job Description Print Preview Quality Engineer Business Unit: Medeco Security...

  • Quality Engineer

    2 months ago


    Salem, United States DSJ Global Full time

    We are a leader in the aerospace manufacturing industry, dedicated to delivering high-quality components and solutions that meet the stringent standards of our clients. We pride ourselves on innovation, precision, and excellence in everything we do.Position Overview:We are seeking a skilled Quality Engineer to join our team. The ideal candidate will have a...

  • Quality Engineer

    2 months ago


    salem, United States DSJ Global Full time

    We are a leader in the aerospace manufacturing industry, dedicated to delivering high-quality components and solutions that meet the stringent standards of our clients. We pride ourselves on innovation, precision, and excellence in everything we do.Position Overview:We are seeking a skilled Quality Engineer to join our team. The ideal candidate will have a...

  • Quality Engineer

    4 weeks ago


    Salem, United States DSJ Global Full time

    We are a leader in the aerospace manufacturing industry, dedicated to delivering high-quality components and solutions that meet the stringent standards of our clients. We pride ourselves on innovation, precision, and excellence in everything we do.Position Overview:We are seeking a skilled Quality Engineer to join our team. The ideal candidate will have a...

  • Quality Engineer

    2 weeks ago


    Salem, United States DSJ Global Full time

    We are a leader in the aerospace manufacturing industry, dedicated to delivering high-quality components and solutions that meet the stringent standards of our clients. We pride ourselves on innovation, precision, and excellence in everything we do.Position Overview:We are seeking a skilled Quality Engineer to join our team. The ideal candidate will have a...

  • Quality Engineer

    4 weeks ago


    Salem, United States DSJ Global Full time

    We are a leader in the aerospace manufacturing industry, dedicated to delivering high-quality components and solutions that meet the stringent standards of our clients. We pride ourselves on innovation, precision, and excellence in everything we do.Position Overview:We are seeking a skilled Quality Engineer to join our team. The ideal candidate will have a...

  • quality engineer

    3 days ago


    Salem, United States Randstad Full time

    quality engineer. salem , virginia posted october 29, 2024 job details summary $70,000 - $80,000 per year permanent bachelor degree category computer and mathematical occupations reference1070506 job details job summary: Permanent Position: Job opening for a Process Quality Engineer in Salem, VA for a leading manufacturer. This position...

  • Quality Engineer

    1 day ago


    Salem, United States Avon Protection Full time

    Job Title: Quality Engineer Location: Salem NH Business Unit: Team Wendy About Avon Technologies: We are a world leader in protective equipment, with a reputation for innovative design, high-performance quality and specialist materials expertise. Our two brands, Avon Protection and Team Wendy, supply our respiratory and head protection portfolio to customers...


  • Salem, Virginia, United States Volvo Group Full time

    Estimated annual salary: $120,000 - $180,000About the RoleWe are seeking a highly skilled Industrial Quality Engineer to join our team in Salem, VA. As a key member of our Group Trucks Purchasing department, you will play a critical role in ensuring the quality of suppliers' products and services.In this position, you will be responsible for monitoring...


  • Salem, United States Generis Tek Inc Full time

    Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Rishi Jadhav at email address Rishi.Jadhav@generistek.com can be reached on # 630-576-1928. We have Contract role for Quality Assurance Analyst for our client Salem OR. Please let me know if you or any of your friends would be interested in this position....


  • salem, United States DSJ Global Full time

    We are a leader in the aerospace manufacturing industry, dedicated to delivering high-quality components and solutions that meet the stringent standards of our clients. We pride ourselves on innovation, precision, and excellence in everything we do.Position Overview:We are seeking a skilled Quality Engineer to join our team. The ideal candidate will have a...


  • salem, United States DSJ Global Full time

    We are a leader in the aerospace manufacturing industry, dedicated to delivering high-quality components and solutions that meet the stringent standards of our clients. We pride ourselves on innovation, precision, and excellence in everything we do.Position Overview:We are seeking a skilled Quality Engineer to join our team. The ideal candidate will have a...


  • Salem, New Hampshire, United States GPD Optoelectronics Corp Full time

    Job OverviewThe Senior Quality Assurance Engineer will play a crucial role in ensuring the quality and reliability of commercial and high-reliability InGaAs and Germanium photodetectors. This position involves working in a microelectronics manufacturing environment, performing quality-related functions such as incoming material inspection, external...


  • Salem, United States AB Volvo Full time

    Transport is at the core of modern society. Imagine using your expertise to shape sustainable transport and infrastructure solutions for the future? If you seek to make a difference on a global scale, working with next-gen technologies and the sharpest collaborative teams, then we could be a perfect match.Volvo Group Purchasing is a team of changemakers that...

  • Assembler III

    2 months ago


    Winston-Salem, United States Progress Rail Services Full time

    10002BR PRS Facility Location: Winston Salem, NC - 329 Job Purpose: • Benefits start on your first day! • Monthly production bonus program! • Employee Referral Bonus! • 401k - 100% Company match up to 6%! • Work in a state-of-the-art, clean facility with a climate-controlled environment! Performs repair work and/or operating specialized...


  • Salem, United States Mastech Digital Full time

    Senior Wafer Fabrication Engineering ManagerSalem, NH 03079 - OnsiteOur client seeks an experienced leader to manage and optimize a semi-automated wafer fabrication facility, oversee photodetector device fabrication, and drive process improvements.Key Responsibilities:Manage wafer processing operations, including photolithography, optical coatings, chemical...


  • Salem, United States Mastech Digital Full time

    Senior Wafer Fabrication Engineering ManagerSalem, NH 03079 - OnsiteOur client seeks an experienced leader to manage and optimize a semi-automated wafer fabrication facility, oversee photodetector device fabrication, and drive process improvements.Key Responsibilities:Manage wafer processing operations, including photolithography, optical coatings, chemical...


  • Winston-Salem, United States CV Library Full time

    QUALITY ENGINEER/INSPECTOR ** SHEFFIELD ** IMMEDIATE START ** PERMANENT ROLE ** £30 - 34k **Due to increased workload our client are now looking for a Quality Engineer/Inspector to join their rapidly expanding business. The role is for someone who makes sure manufactured products meet requirements using tools and guidelines.Key ResponsibilitiesHelping to...

  • Assembler III

    2 months ago


    Winston-Salem, United States Progress Rail Services Full time

    9966BR PRS Facility Location: Winston Salem, NC - 329 Job Purpose: • Benefits start on your first day! • Monthly production bonus program! • Employee Referral Bonus! • 401k - 100% Company match up to 6%! • Work in a state-of-the-art, clean facility with a climate-controlled environment! 2nd shift position Performs repair work and/or...