Quality engineer/process engineer job description

Ensure implementation and compliance of plant quality systems to required quality and manufacturing standards including customer specific standards and tools for error prevention, continuous improvement and problem solving at all stages of product realization.

- Implement quality and manufacturing systems and coordinate quality plans with on-going compliance to customer requirements as determined through the Advanced Quality Planning. Must be familiar with Core Tool Strategies, such as FMEA, PPAP, MSA, and Process Control.

- Ensure compliance of quality and manufacturing systems to all required standards including customer specific requirements.

- Create and update inspection plans for all phases of process from incoming to final audit. Train incoming inspectors and quality engineers on inspection procedures.

- Point of contact for customer complaints. Facilitates the customer complaint management and problem solving processes to ensure resolution and continual improvements at product, process, and system levels as necessary. Regular update of internal, customer and supplier complaints. Advanced skills in Problem Solving a plus.

- Validate and release measurement gages for new programs in application of statistical tools. Perform Gage Repeatability and Reproducibility studies on current and new gages.
- Coordinate and perform (as required) internal process and system audits.

LANGUAGE SKILLS:
Ability to read, analyze, and interpret common scientific and technical journals, general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from managers, employees, and customers. Ability to respond to common inquiries or complaints from customers. Ability to interact with global counterparts.

MATHEMATICAL SKILLS:
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY:
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs etc.,) in its most difficult phases. Ability to define problems collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Benefits include:
10 Paid Holidays; eligible for on first day!
Vacation and Personal Time
Medical, Dental, Vision
401K plan with company match
Company provided life insurance, with optional supplemental life insurance
Short term and long term disability

PTI Engineered Plastics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment.

Help us build the DNA of tech.

Vishay manufactures one of the world's largest portfolios of discrete semiconductors and passive electronic components that are essential to innovative designs in the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets. We help the world's most in-demand technologies come to life. Every day our products touch your life and the lives of people across the world, though you likely do not know it. Come join us and help us build The DNA of tech.™

Where You'll Work & The Scope:

Vishay, Marshall Minnesota, is currently seeking a full-time Quality Process Engineer responsible for supporting product manufacturing including prototype-to-product transition, manufacturing process development, test process development, and material and configuration management.

How You'll Help Us Build the DNA of Tech:

* Provide engineering support to production lines and test equipment.

* Evaluate customer specifications and convert requirements into internal specifications for design, test, and manufacturing process.

* Improve quality and efficiency through process automation where practical.

* Execute process validation activities including, but not limited to, pFMEA, Control Plan, GRR studies, etc.

* Perform product testing, analyze test data, and publish test reports.

* Recommend and oversee outside service providers for fabrication, testing, and other services.

* Manage projects, develop project plans, and lead project meetings.

* Interpret failure data and initiate appropriate associated improvement actions.

* Develops product and process performance measurements including generating monthly quality reports for management review, performing trend analysis of quality data, and generating special quality reports for customers.

* Assists in ISO-9001 and QS9000 audits.

* Seeks out areas of refinement of materials and methods for cost reduction and quality improvement and works directly with suppliers to identify/resolve quality issues.

* Performs supplier quality audits and assessments.

* Assists with quality surveys by customers or government teams.

Experience You'll Need:

* Bachelor of Science degree in electrical, mechanical, industrial, or quality engineering or similar degree from an accredited college or university.

* Experience with Lean/Six Sigma a plus.

* Proficient with Microsoft Office Suite.

* Excellent problem-solving skills and ability to identify root cause and determine appropriate corrective actions.

* Strong communication and interpersonal skills.

This position requires access to information subject to the International Traffic in Arms Regulations and/or the Export Administration Regulations. As such, this position is open only to applicants who qualify as "U.S. Persons" according to U.S. federal law.

Vishay offers a comprehensive suite of benefit programs including health care coverage, financial support programs and other resources designed to help you achieve your personal and professional goals. With us, you'll experience unique career paths, an open and collaborative culture, a stable business that will be there for you, and opportunities to work globally and locally. Do you have the skills we need? Are you ready to power your career as you power the world? If so, apply today.

Vishay is an AAP and Equal Opportunity Employer

The Company

The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics, a bio Merieux company, has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific's solution provides results 2 days sooner than existing methods, saving patients suffering from drug-resistant infection.

The Job

Responsible for ensuring medical devices are developed, manufactured, and tested in accordance with FDA and other regulatory requirements. Implements and enforces policies and procedures that will maintain adherence to FDA Quality Systems Regulations, ISO 13485, and other applicable country regulations. Maintains an active quality presence in manufacturing areas and will continuously strive for quality improvement.

Primary Duties

+ Participate in regulatory inspections, audits, investigations, and inquiries regarding the control and assessment of manufacturing quality.

+ Participate in site Internal audit and compliance review programs.

+ Perform data analysis of field complaints and determine when further investigation is necessary.

+ Conduct periodic trend reporting of negative quality indicators (nonconformances, scrap, field complaints) and provide trend reports to management as required.

+ Serve as quality representative for process risk management activities. Review and revise exiting risk assessments as necessary through analysis of manufacturing and field data feedback.

+ Participate and provide quality guidance for supplier changes

+ Evaluate quality status of nonconforming material (incoming and in-process). Ensure the disposition of non-conforming materials meet all site and regulatory requirements.

+ Review and approve Validations, Verifications, Qualifications, Scientific Studies, and Technical Reports, as required.

+ Participate in site CAPA activities, including root cause analysis. Coordinates the implementation of corrective actions and preventive measures and measures effectiveness of action plans.

+ Provide input and approval of QC inspection methods as needed.

+ Provide quality review/approval for change management activities.

+ Review Bill of Material (BOMs), Assembly Procedures, Part Drawings, and Component Specifications for accuracy.

+ Monitor manufacturing activities and promote quality through active relationships with manufacturing floor. Monitor, review and approve any planned or unplanned process deviations.

+ Ensures complete and correct Device History Records are compliant to quality procedures through review and periodic audits.

+ Participate in the development and execution of quality focused training (GMP, risk analysis, nonconformances, deviations, etc.) to reinforce quality mindsets in other departments. Support continuous improvement projects as needed.

Qualifications

Training and Education

BS in scientific or engineering field and a minimum of 5 years' experience in Manufacturing/Quality Engineering/Quality Systems

Experience

+ For level 9: BS in scientific or engineering field and a minimum of 5 years' experience (3 years with MS degree)

+ For level 8: BS in scientific or engineering field and a minimum of 8 years' experience (5 years with MS degree)

+ Competence in the selection and use of Quality Engineering Tools and Techniques.

+ Medical Device or other FDA regulated industry experience required

+ Must possess effective written and verbal communication skills.

+ Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).

+ Must have knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).

+ Certification in one of the following is desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt .

Knowledge, Skills, and Abilities

Make decisions based on defined guidelines and procedures. Performs a wide variety of inspection and audit root cause analysis and applies problem solving skills to determine root causes and appropriate corrective actions. Is empowered to make decisions impacting product quality, quality records, and deviation resolution.