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Become A Principal Quality Engineer

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Working As A Principal Quality Engineer

  • Making Decisions and Solving Problems
  • Getting Information
  • Identifying Objects, Actions, and Events
  • Interacting With Computers
  • Communicating with Supervisors, Peers, or Subordinates
  • Deal with People

  • $92,600

    Average Salary

What Does A Principal Quality Engineer Do At Medtronic

* Ensure area is compliant with internal and/or external specifications, regulations and standards such as ISO.
* Create and update procedures as assigned, related to the quality system, operations, and product testing.
* Interface and coordinate with other Medtronic facilities to resolve issues and implement best practices.
* Lead and/or participate in corrective/preventive action teams in resolving production, customer and supplier issues (e.g., nonconformances, sCAPA or CAPA activities, audit findings, complaint investigations, etc.).
* Apply and understand statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement.
* Communicate significant issues or developments identified during quality activities and provide recommended process improvements to team or management.
* Review equipment and process validations, changes, nonconformances, etc., in order to ensure compliance and assess the impact on product reliability, process capability and compliance status.
* Review and approve test method validation and stability plans and reports.
* Provide technical support for laboratory testing in order to ensure root cause analysis of all issues identified by test and investigative results.
* Work closely with Supplier Quality to develop and maintain inspection procedures for materials, components and products to support receiving inspection, manufacturing and development.
* Lead or participate in supplier audits / assessments, ensuring compliance with associated Medtronic policies and QSR / ISO requirements.
* Support internal and external site audits and inspections.
* Perform combination product lot release activities per approved process.
* Approved finished good label issuance per approved process.
* Perform other related duties as assigned.
* Must Have: Minimum Qualifications
* years experience in the medical device, pharmaceutical or highly regulated industry.
* years combined experience in Quality/Regulatory, Manufacturing, Design, Continuous Improvement, Sourcing, Laboratory and/or equivalent functi

What Does A Principal Quality Engineer Do At J&J Family of Companies

* Directs, controls, and facilitates projects relating to the introduction of new products and improvement of new/existing processes in support of the Quality Assurance business unit.
* Including both executing and approving validation activities.
* Develops, oversees, and maintains budgets as necessary relating to current and future projects.
* Facilitates regular project updates and reviews.
* Provides input into Quality Assurance business unit strategic plans and activities.
* Ensures compliance of work requirements, coordinates work flow and provides guidance in the resolution of routine and non-routine problems or areas of concern.
* Establishes goals and communicates changes in policies and procedures assuring compliance to regulatory requirements.
* Monitors work performance and flow of department operations.
* Performs other related duties as assigned by management

What Does A Principal Quality Engineer Do At Danaher Corporation

* Achieve yearly External (Customer) Quality targets through:
* Effective and efficient Daily Management leadership
* Effective and efficient Problem Solving using the Danaher Problem Solving Process
* Action Plan development and execution leadership
* Cross-functional project management
* Quality Kaizen / Continuous Improvement Leadership
* Key decision rights over NPI sign off, change control sign off, Quality Agreements, POR/NCR/CAPA closures, Recall recommendations and QMS design recommendations.
* Assume a leadership role to ensure the successful training, execution, and sustainment of DBS and QMS activities to drive quality results, across the Value Stream.
* Lead the development of a high performing team of QE’s and QE Technicians capable of meeting near term and longer term quality improvement objectives.
* Support their career development through formalized career planning and support plans.
* Administer quality policies/procedures and provide Quality Assurance supervision for the value stream; to include auditing and product/process performance measure development and management for the value stream.
* Assume a leadership role to actively manage Customer Complaint (Plant Escapes – Product Occurrence Records – “POR”) CAPA process, non-conforming product, associated corrective/preventive actions using 8D process and to drive closure within the targeted turn-around times.
* This includes, providing external POR/PPM data, trend charts/analysis and leading the implementation of improvements focused on prioritized root causes, with sustainment ensured.
* Relate with customer/government/FAA for all Quality matters to include customer audits, customer telcons, and resolution of any corrective actions, quality escape action reviews and zero defect initiatives, as required for the Value Stream.
* This includes technical presentations at customer sites, as required.
* Work closely with Sales, R&D, and Manufacturing to optimize the company's products and relationships with our customers including customer specification reviews with gap closure ownership.
* The value stream quality leadership role for New Product Introduction over the new product development / introduction process to include DFMEA/PFMEA and PPAP/APQP activities, to ensure internal yield and external PPM goals are met from the time of launch.
* Support Supplier Quality Engineer for driving improvements for Supplier related issues (SCARs), work closely with purchasing and strategic sourcing to select/maintain/drop suppliers listed based on their performance.
* Manage the follow-up and verification of CAPAs performed by QE/QE Techs to assure no recurrence.
* Adhere to corporate escalation and reporting guidelines.
* Manage the Certified Operator Program for the value stream, review/action audits results performed by the QE/QE Techs.
* Oversee the development and assurance of effective quality inspection planning performed by QE/QE Techs and ensure the customer quality requirements are identified and implemented for the Value Stream.
* Oversee and manage the QE/QE Tech support to ensure appropriate actions are taken.
* May perform inspection, first article inspections and/or source inspection, as required.
* Job duties and responsibilities include but are not limited to those listed.
* Qualification
* IV

What Does A Principal Quality Engineer Do At Kite Pharma, Inc.

* Author quality system trend reports and develop metric control plans for management review reporting.
* Establish meaningful thresholds for quality system metrics.
* Develop or enhance metric control plans for operational review areas including manufacturing supply management, quality system management, and product and process management.
* Discuss data trends with functional departments, learn special causes and common causes for variation.
* Teach teams how to interpret data trends and appropriate action plans for out of trend results.
* Collaborate with cross functional teams to solve problems and analyze data.
* Facilitate monthly metric review meetings at the commercial manufacturing site.
* Enhance and develop quality risk management tools and methodologies and apply to the commercial quality system.
* Facilitate and or lead execution of risk management activities at the commercial site.
* Facilitate and lead complex investigations, utilize structured approach to root cause analysis and corrective action plan development.
* Lead development of the annual product quality review templates, data analysis and report creation.
* Compile data, analyze data, draw data driven conclusions and develop risk based action plans through the CAPA system for management review outputs and annual product quality reviews.
* Review and approve validation documents for kite systems and processes.
* Participate as the quality lead on cross-function project teams to implement new technology and make enhancements to the existing processes.
* Provide work direction and guidance to staff to assure completion of assigned tasks and other duties

What Does A Principal Quality Engineer Do At Medtronic

* Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
* Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases.
* Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support the market needs.
* Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
* Assist in the creation of verification and validation test plans.
* Oversee testing and analysis for standards and product requirements compliance.
* Provide guidance and direction for sample size and statistical analysis of verification and validation test results.
* Utilize Statistics stools experience such (e.g.
* Minitab).
* Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
* Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.
* Review Design History Files and Technical Files for conformance to applicable requirements.
* Assist, when appropriate with internal and supplier audits.
* Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
* Support the Regulatory Department in writing technical submissions.
* Adheres to the competencies and skills for the specified position as defined in the Quality Professional Leveling Matrix.
* Other duties as assigned with or without accommodation

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How To Become A Principal Quality Engineer

Industrial engineers must have a bachelor’s degree. Employers also value experience, so cooperative education engineering programs at universities are also valuable.

Education

Industrial engineers need a bachelor’s degree, typically in industrial engineering. However, many industrial engineers have degrees in mechanical engineering, electrical engineering, manufacturing engineering, industrial engineering technology, or general engineering. Students interested in studying industrial engineering should take high school courses in mathematics, such as algebra, trigonometry, and calculus; computer science; and sciences such as chemistry and physics.

Bachelor’s degree programs include lectures in classrooms and practice in laboratories. Courses include statistics, production systems planning, and manufacturing systems design, among others. Many colleges and universities offer cooperative education programs in which students gain practical experience while completing their education.

A few colleges and universities offer 5-year degree programs in industrial engineering that lead to a bachelor’s and master’s degree upon completion, and several more offer similar programs in mechanical engineering. A graduate degree allows an engineer to work as a professor at a college or university or to engage in research and development. Some 5-year or even 6-year cooperative education plans combine classroom study with practical work, permitting students to gain experience and to finance part of their education.

Programs in industrial engineering are accredited by ABET.

Important Qualities

Creativity. Industrial engineers use creativity and ingenuity to design new production processes in many kinds of settings in order to reduce the use of material resources, time, or labor while accomplishing the same goal.

Critical-thinking skills. Industrial engineers create new systems to solve problems related to waste and inefficiency. Solving these problems requires logic and reasoning to identify strengths and weaknesses of alternative solutions, conclusions, or approaches to the problems.

Listening skills. These engineers often operate in teams, but they also must solicit feedback from customers, vendors, and production staff. They must listen to customers and clients in order to fully grasp ideas and problems the first time.

Math skills. Industrial engineers use the principles of calculus, trigonometry, and other advanced topics in mathematics for analysis, design, and troubleshooting in their work.

Problem-solving skills. In designing facilities for manufacturing and processes for providing services, these engineers deal with several issues at once, from workers’ safety to quality assurance.

Speaking skills. Industrial engineers sometimes have to explain their instructions to production staff or technicians before they can make written instructions available. Being able to explain concepts clearly and quickly is crucial to preventing costly mistakes and loss of time.

Writing skills. Industrial engineers must prepare documentation for other engineers or scientists, or for future reference. The documentation must be coherent and explain their thinking clearly so that the others can understand the information.

Licenses, Certifications, and Registrations

Licensure is not required for entry-level positions as an industrial engineer. A Professional Engineering (PE) license, which allows for higher levels of leadership and independence, can be acquired later in one’s career. Licensed engineers are called professional engineers (PEs). A PE can oversee the work of other engineers, sign off on projects, and provide services directly to the public. State licensure generally requires

  • A degree from an ABET-accredited engineering program
  • A passing score on the Fundamentals of Engineering (FE) exam
  • Relevant work experience, typically at least 4 years
  • A passing score on the Professional Engineering (PE) exam

The initial FE exam can be taken after one earns a bachelor’s degree. Engineers who pass this exam are commonly called engineers in training (EITs) or engineer interns (EIs). After meeting work experience requirements, EITs and EIs can take the second exam, called the Principles and Practice of Engineering.

Several states require engineers to take continuing education in order to keep their licenses. Most states recognize licenses from other states, as long as the other state’s licensing requirements meet or exceed their own licensing requirements.

Advancement

Beginning industrial engineers usually work under the supervision of experienced engineers. In large companies, new engineers also may receive formal training in classes or seminars. As beginning engineers gain knowledge and experience, they move on to more difficult projects with greater independence to develop designs, solve problems, and make decisions.

Eventually, industrial engineers may advance to become technical specialists, such as quality engineers or facility planners. In that role, they supervise a team of engineers and technicians. Obtaining a master’s degree facilitates such specialization and thus advancement.

Many industrial engineers move into management positions because the work they do is closely related to the work of managers. For more information, see the profile on architectural and engineering managers.

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Principal Quality Engineer jobs

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Principal Quality Engineer Demographics

Gender

  • Male

    77.6%
  • Female

    19.8%
  • Unknown

    2.6%

Ethnicity

  • White

    69.2%
  • Asian

    15.3%
  • Hispanic or Latino

    10.5%
  • Unknown

    4.1%
  • Black or African American

    1.0%
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Languages Spoken

  • Spanish

    50.0%
  • Mandarin

    25.0%
  • Chinese

    25.0%

Principal Quality Engineer

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Real Principal Quality Engineer Salaries

Job Title Company Location Start Date Salary
Principal Quality Engineer Risk Management Solutions, Inc. Newark, CA Nov 07, 2016 $145,000 -
$185,000
Principal Mobile Quality Engineer II Constant Contact San Francisco, CA Mar 29, 2016 $138,500 -
$150,000
Principal Quality Engineer Herbalife International of America, Inc. Los Angeles, CA Dec 16, 2016 $136,356
Principal Quality Engineer EMC Corporation Santa Clara, CA Jun 29, 2016 $132,218
Principal Quality Engineer St. Jude Medical, Inc. Selma, CA Oct 20, 2014 $130,000
Principal Quality Engineer, Performance Trinet Hr Corporation San Leandro, CA Apr 25, 2014 $126,048
Principal Data Quality Engineer Parexel International Billerica, MA Sep 08, 2015 $125,000
Principal Quality Engineer II Axway Inc. Phoenix, AZ May 01, 2016 $125,000
Principal Quality Engineer EMC Corporation Santa Clara, CA Apr 06, 2016 $120,349 -
$132,218
Principal Quality Engineer Staples, Inc. Seattle, WA Dec 24, 2016 $120,000
Principal Quality Engineer Sonus Network, Inc. Fremont, CA Mar 30, 2015 $118,914 -
$135,000
Principal Quality Engineer St. Jude Medical, Implantable Electronic Systems Division Selma, CA Sep 10, 2015 $118,337
Principal Quality Engineer PTC Inc. Needham, MA Feb 12, 2016 $112,632
Principal Quality Engineer Staples, Inc. Broomfield, CO Dec 22, 2014 $110,000
Principal Quality Engineer Abiomed, Inc. Danvers, MA Dec 10, 2012 $110,000
Principal Quality Engineer Abiomed, Inc. Danvers, MA Dec 01, 2012 $110,000
Principal Quality Engineer Altisource Solutions Inc. Boston, MA Jun 06, 2016 $109,763 -
$120,000
Principal Quality Engineer PTC Inc. Needham, MA Nov 16, 2016 $109,762
Principal Quality Engineer Microstrategy Inc. Tysons Corner, VA Sep 27, 2016 $108,139
Principal Quality Engineer Salesforce.Com, Inc. Indianapolis, IN Jul 02, 2015 $101,130
Principal Quality Engineer Intralinks, Inc. Waltham, MA Oct 12, 2016 $99,800 -
$125,000
Principal Quality Engineer Intralinks, Inc. Waltham, MA Dec 10, 2016 $99,800 -
$125,000
Principal Quality Engineer (Medical Devices) Carefusion Corporation San Diego, CA May 01, 2012 $99,025
Principal Quality Engineer PTC Inc. Needham, MA Nov 14, 2016 $98,900
Principal Quality Engineer, Hardware Carefusion Corporation San Diego, CA Jan 09, 2014 $98,738
Principal, Quality Engineer Cyberonics, Inc. Houston, TX Sep 20, 2015 $97,989 -
$109,381
Principal, Quality Management Mercury Insurance Services, LLC (D/B/A Mercury Insurance Group) Brea, CA Feb 18, 2016 $96,000 -
$176,297

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Top Skills for A Principal Quality Engineer

SupplierQualityEnsureComplianceCorrectiveActionISOCapaRegulatoryComplianceQualitySystemInternalAuditsFDAAssuranceSigmaNewProductDevelopmentMedicalDeviceValidationProtocolsProductQualityIssuesQARProcessImprovementCustomerComplaintsFmea

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Top Principal Quality Engineer Skills

  1. Supplier Quality
  2. Ensure Compliance
  3. Corrective Action
You can check out examples of real life uses of top skills on resumes here:
  • Facilitated supplier quality development initiatives; conducted supplier assessment audit.
  • Conducted equipment, process and material validations to ensure compliance with facility procedures, regulatory requirements and industry standards.
  • Performed data trend analysis and recommended corrective actions.
  • Isolated and corrected a previously incapable process that that led to $2,4M Yr. in revenue for a delivery catheter.
  • Developed a Process Capability Methodology for purchase parts.

Top Principal Quality Engineer Employers

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