Quality Engineer I

• Performs all measures of quality planning for incoming and in-process inspections as well as final acceptance - Develop and support the generation of Flow charts, FMEAs and Control plans

• Supports plant activities in process validation, process capability issues and customer issues, initiates corrective and preventive action, with an eye to increased capability, reduced inspection time/effort, customer satisfaction and supports Quality System implementation.

• Transition products from development to manufacturing by composing and/or reviewing protocols and reports for the IQ/OQ/PQ process

• Establish statistical standards of performance by providing support and expertise in Gage R&R, DOE, reliability strategy, and analytical problem-solving techniques.

• Assures compliance to in-house and external specifications and standards, such as GMPs, GDPs, ANSI and ISO regulations.

• Performs/leads with the investigation of root cause and determination of corrective and preventive actions relating to NCMRs and CAPAs Interfaces with manufacturing and engineering to resolve quality issues for new and existing product lines.

• Works on continuous improvement projects from beginning to end. Characterizes the problem, identifies key process inputs, determines optimal operating window, implements controls to maintain output at desired level and quantifies the improvement in savings, avoidance, or value.

Qualificationsarrow_right

• Bachelor of Science degree in Engineering or equivalent

• 2 - years of experience as a Quality Engineer or quality focused internship

• 2 + years of experience in a manufacturing environment of medical or health care products and knowledge of injection molding processes

• Understanding or experience in performing and executing Gage R&R studies using Minitab

• Demonstrated knowledge in Quality System Requirements/Good Manufacturing Practices.

• Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, multi-meters, manometers, pull test and other inspection equipment.

• Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc., along with working knowledge of SolidWorks and AutoCAD software, 2D& 3D, Microsoft Project, and SAP

• Understanding of continuous improvement methodologies including Lean/Six Sigma and validation.

• Detail orientation; strong organizational skills and bias for action.

• Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work

• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).

• Execute tasks in a timely manner without direct supervision.

• Ability to travel as required (minimal).

• Preferred Qualifications

• Certified Quality Engineer (CQE) and or Certified Quality Auditor (CQA).

• Lean/Six Sigma certification.

• Injection molding manufacturing.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.