Quality Manager # 26-28094

Us Tech Solutions; Warsaw (IN); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

US Tech Solutions is seeking a Quality Engineer to drive quality improvement across manufacturing and development teams. You will gather data, apply quality methods, and ensure products meet requirements through audits, inspections, and testing.

Responsibilities include evaluating processes, establishing quality plans, monitoring performance, and collaborating with suppliers to meet ISO/QSR standards and product performance goals.

Qualifikationen

• Bachelor's degree in engineering or CQE-certification required.
• 5–7 years of quality engineering experience, medical devices preferred.
• Strong knowledge of ISO/QSR regulations and design controls.

Aufgaben

• Evaluate processes/equipment to meet quality requirements.
• Establish and monitor quality plans for equipment/processes.
• Audit, inspect and test to ensure conformance.
• Collaborate with manufacturing, sourcing and development.
• Maintain department and project budgets.

Kenntnisse

Blueprint reading

GD&T

QSR/ISO regulations

FMEA

Product testing

Optical comparators

CMMs

Statistics

Process control

Team collaboration

Communication

Ausbildung

Bachelor of Science in engineering

CQE certification

CRE preferred

Jobbeschreibung

12 Months--Possible extension

Duration:

12 Months--Possible extension

Description:

Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Client to implement Client’s Quality goals.

Principal Duties and Responsibilities:

• Evaluating process methods and equipment to meet performance and quality requirements.
• Establishing quality plans for equipment and processes for general and specific product performance needs
• Monitoring performance of processes to a standards
• Applying ISO and QSR requirements to processes and procedures for client and outside suppliers; Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled
• Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations
• Developing and maintaining department and project budgets

Duration:

12 Months--Possible extension

Description:

Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Client to implement Client’s Quality goals.

Principal Duties and Responsibilities:

• Evaluating process methods and equipment to meet performance and quality requirements.
• Establishing quality plans for equipment and processes for general and specific product performance needs
• Monitoring performance of processes to a standards
• Applying ISO and QSR requirements to processes and procedures for client and outside suppliers; Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled
• Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations
• Developing and maintaining department and project budgets

Expected Areas of Competence

• Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
• Facilitates team efforts on quality engineering projects.
• Ability to deliver, meet deadlines and have results orientation.
• Able to communicate both orally and in written form to multiple levels of the company.
• Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
• Knowledge of statistics, process control, and process capability
• Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
• Thorough knowledge base of existing client’s products and a basic understanding of competitive products

Education/ Experience Requirements

• B.S. in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).
• Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.
• 5-7 years’ experience in a Quality Engineering role; Medical device strongly preferred, or an equivalent combination of education and experience.
• Combination of education and experience may be considered (in evaluating experience relative to requirements)

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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