Quality Manager

Lancesoft; Warsaw (IN); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Lancesoft in the United States is seeking a Quality Engineer to gather relevant data, analyze issues, and drive solutions across departments. You will participate in audits, inspections, and tests to ensure products meet established requirements and standards, working with suppliers and experts outside Lancesoft to implement quality goals.

Your responsibilities include evaluating processes, establishing quality plans, monitoring performance, and applying ISO/QSR requirements.

Formación

• B.S. in engineering or equivalent with CQE certification preferred.
• CQE certification is encouraged.
• 5–7 years of quality engineering experience required.
• Medical device experience preferred.

Responsabilidades

• Plan and lead quality projects ensuring conformance to requirements.
• Establish quality plans for equipment and processes.
• Audit, inspect, and test activities to verify standards.
• Collaborate with multiple departments and suppliers to meet Client quality goals.

Conocimientos

Teamwork

Deadline-driven

Written & oral communication

Blueprint reading

GD&T

QSR/ISO compliance

FMEA

Product testing methods

Statistical analysis

Educación

B.S. in engineering or related field (CQE preferred)

CQE certification

CRE certification

Herramientas

MS Office Suite

Optical comparators

CMMs

Descripción del empleo

Duties

Job Summary 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 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.

Skills

Expected Areas of Competence (i.E. KSAs) 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 products and a basic understanding of competitive products.

Education

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)