Quality Assurance Quality Control Engineer Jobs in Summit, Ohio

Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.

0 - 3 years of manufacturing experience, or an equivalent combination of education and experience.

Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.

Feel stuck – we offer great opportunities to advance and learn

A quick learner who is always ready to gain depth of knowledge in manufacturing processes

Serves as a quality representative to assigned manufacturing areas and/or customers.

Proven problem solving skills, core tools and ISO 9001-IATF 16949 knowledge

proven problem solving skills, core tools and ISO 9001-IATF 16949 knowledge

Free Training to upgrade your skills

Payrate or Pay range $70-95,000

Working in the automotive industry, the ability to engage with customers

Certified Quality Engineer and/or Certified Lead Auditor is preferred, but not mandatory.

Ensure processes comply with the Quality Management System

Complete process audits based on requirements of certifications and QMS

High computer competence, including MRP, MS Office, Database management

Bachelor’s degree in technical field preferred, or relative experience

Strong analytical, problem-solving, and decision-making, critical thinking, and leadership skills

Excellent verbal and written communication skills

Assist in the implementation of lean principles in the quality systems and program management on new products

Assist in the development of quality systems to meet internal and external customer requirements

Plan and participate in improvement activities to ensure quality systems continue to meet and exceed all customer requirements

Develop documents to support ISO/TS 16949 requirements (PPAP, FEMA's, Control Plans, PSW'S, etc.)

Bachelor's degree in Engineering or related STEM degree OR have experience in a Quality function in a manufacturing environment

Experience in plastic injection molding, chrome plating, and/or assembly operations

Provide engineering technical knowledge to manage nonconforming product evaluation, execution, and containment to minimize impact to plant operations or customers.

2-6 years of experience based on education

Nonconforming procedure - Knowledge of QMS and government regulation requirements

Manage/schedule dimensional/formability activities during New Model/MP.

Create and maintain Stamping/Plastics dimensional/formability reporting and documentation for the department to manage overall part spec compliance.

Make, update and revise training material for dimensional data collection processes and conduct training to improve department skill level.

Support quality team on visual management boards & implementation of 5S standards

Experience leading and/or executing risk assessment activities such as FMEA, Fault Tree Analysis, 5 Why, and Fishbone Analysis

Highly skilled in statistical methods, Gage R&R, statistical process control, sampling plans, and design of experiments

Strong computer skills including Microsoft Office Package (Excel, Word, etc.)

Special assignments as assigned from the Quality Manager

Bachelor’s of Science in Engineering, Chemistry, or an applied science

Manage the customer specific requirements and offer technical support.

Team working skills: Analytical skills with knowledge of MS Excel.

Responsible for planning, implementing and managing compliance of assembly processes with internal and external safety, quality and regulatory standards and requirements.

Minimum Education Required : Bachelor’s Degree

Strong planning and prioritizing skill

Good communication and interpersonal skills

Facilitation of deviation, CAPA, change control, and document control programs and review of related reports with subject matter experts and management.

Performing batch release of radioisotopes which includes product labeling review, QC Chemistry and Microbiology testing review, and batch record execution review.

Consider, develop, and implement continuous improvement initiatives to QA-related processes.

Additional licensures are necessary as required by regulatory authorities

Know Your Rights English Version

Know Your Rights Spanish Version

Knowledge and experience with quality systems, concepts, regulatory compliance requirements and applied statistical concepts.

Assists in CAPA, complaint management, medical device and vigilance reporting.

Assists in all aspects of supplier management.

BA/BS degree in a Life Science, Engineering, Physical Science, a related field of study or equivalent work experience and/or professional qualifications.

Work with all other departments to assure product design conforms to internal specifications, customer, and regulatory requirements.

At least 2 years of Quality Engineering experience in a manufacturing environment.

Strong interpersonal skills, high-impact communication skills, project management skills

Lead and Manage complex problem solving analysis, investigations, report writing, and containment/repair activity utilizing quality engineering principles (Complex Analysis)

Analyze proposed countermeasures, judge their effectiveness once implemented, and manage change point control (MQS Review and Reporting)

Bachelor’s Degree in Engineering (e.g. Mechanical, Technical Design) or equivalent experience

Entry Level Engineering Position: Bachelor’s Degree in Engineering Required or 6 years equivalent experience

Proficient in Catia & Enovia skills – capable of producing and operating 2D/3D models

Analyzes all quality information (M.O.S., C.O.Q., SPC, etc.), prepares summaries and reports to management.

Interfaces with internal customers to provide knowledge, feedback and training as needed.

QUALITY ENGINEER NEEDED - GREENWICH, OHIO AREA

Conducts plant internal quality systems audits.

Maintains the plant quality preventive and corrective action and documentation system.

Assists in the implementation of corporate and plant quality policies and procedures.

• Experience in Java, Selenium/ Cucumber, BDD framework.

• Excellent written and verbal communication skills.

• Work closely with cross functional teams in understanding the requirements

• Report defects in a timely fashion and work to manage defects until issues are resolved.

• Build tools, frameworks, and other infrastructure needed to support automation.

• Design, code, and implement automation framework & tests in physical and virtual environments

Education qualification (technical background, bachelor’s degree preferred)

Demonstrates basic knowledge of FDA/ISO requirements.

Has basic knowledge of theories, practices and procedures in a job family or skill

Applies knowledge and skills to complete own work

Experience needed (3-5 years quality experience preferred)

Demonstrates basic knowledge of quality engineering policies, principles and best practices.

A minimum of 5 yrs experience in a like manufacturing environment in Quality, Engineering or Production.

Substantial experience in a high volume-manufacturing environment, preferably automotive.

Experience of dealing with customers and suppliers.

Investigate root cause of internal quality rejections and implement corrective actions

Monitor ongoing compliance with quality policies and procedures.

Assist in the continuous improvement of manufacturing processes in line with changing organizational needs and market conditions.

Experience with the implementation, certification, and operation of an ISO 17025 quality management system

Five (5) years of experience in Quality Control or Quality Assurance roles, writing quality plans for testing projects and cases

Excellent communication skills with the ability to develop reports and presentations

Excellent analytical and problem-solving skills, with attention to detail

Must be comfortable with some level of ambiguity and fluctuating responsibilities

To learn more about Purdue’s benefits summary

Addressing customer product issues, requests, complaints, and concerns, driving to efficient closure

Employing proactive quality monitoring to anticipate and prevent product quality issues and manufacturing constraints that impact customer satisfaction

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3+ years’ experience in Software Quality Assurance, ideally working within an n-tier environment

Experience leading test efforts and meeting quality objectives on time

Excellent interpersonal skills, both written and verbal

Critical thinking and problem-solving skills

Experience working within Agile teams

Pay & Benefits Data (in accordance with the Equal Pay and Opportunities Act)

Collaborate with software developers, product managers, and other stakeholders to understand project requirements and specifications.

Stay updated with industry best practices, emerging technologies, and quality assurance trends to continuously enhance your skills and knowledge.

Experience or knowledge of software development life cycle (SDLC) and agile methodologies.

Familiarity with testing tools, bug tracking systems, and test management software.

Bachelor's degree in Computer Science, Software Engineering or related degree, or equivalent educational/work experience.

Career development: CCMSI offers robust internships and internal training programs for advancement within our organization.

Have strong organizational and time management skills.

Assist Quality Manager and Lab Director with scheduling and priority sample assessment.

Experienced in quality control of records and data

Obtained knowledge of FDA, USP, and similar cGMP/GDP regulations

Experienced in microbiology and chemistry testing, contract-lab activities

A comprehensive benefits package that includes health, dental, and flexible spending accounts.

Intermediate knowledge of software testing concepts and test design techniques, such as blackbox, greybox, integration, regression, exploratory testing.

Basic knowledge of Non-functional testing concepts, such as performance & security testing.

Intermediate knowledge on tools such as Selenium, Fiddler, Jmeter, DevTools using Python and Java as the languages

Participates on one or more decentralized scrum teams accountable for delivering on sprint goals.

Develops and executes functional and semi-complex automated tests by taking a risk-based approach, using available testing processes and tools.

Provides quality engineering perspective when determining the quality of product prior to code deployment.