Quality Engineer I

Freudenberg Group•Beverly, MA

1d•Onsite

About The Position

Working at Freudenberg: We will wow your world! This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments. The Quality Engineer I performs all measures of quality planning for incoming and in-process inspections as well as final acceptance. This role involves handling multiple projects and tasks from product inception through product launch and maintenance, ensuring products meet quality standards consistent with internal quality policy. The engineer supports plant activities in process validation, process capability issues, and customer issues, initiating corrective and preventive actions to increase capability, reduce inspection time/effort, and enhance customer satisfaction. They also support Quality System implementation, transition products from development to manufacturing, establish statistical standards of performance, and assure compliance to in-house and external specifications and standards.

Requirements

Bachelor's Degree in Engineering or related field.
Minimum of 3 years of experience as a Quality Engineer
Minimum of 3 years of experience in a manufacturing environment of medical or health care products and knowledge of injection molding processes

Nice To Haves

Certified Quality Engineer (CQE) and or Certified Quality Auditor (CQA) preferred.
Lean/Six Sigma certification preferred.
Project management experience preferred.
Experience with ERP systems such as SAP preferred

Responsibilities

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
Handle multiple projects and tasks, from product inception through product launch and maintenance.
Play an active role in the processes to ensure products meet quality standards consistent with internal quality policy.
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.
Establish manufacturing inspection, sampling and statistical process control methods and procedures to assure the quality of manufactured products.
Assures compliance to in-house and external specifications and standards, such as GMPs, GDPs, ANSI and ISO regulations.
Support customer and ISO audits for assigned projects and support internal audit programs as an auditor.
Identifies and highlights any problem issues associated with quality.
Provides input for solutions to problems identified.
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.
Help control the nonconforming product/MRB process.
Draft reports, work instructions, and other technical documents.
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
Support the schedule and day to day tasks for the quality department to ensure internal and external needs are met in a timely manner
Provide training to in-house personnel regarding instructions and standards of work.
Train inspection personnel on entries and record utilizing, measurement equipment, SAP, best quality practices etc.
Participate and support in safety and lean/continuous improvement initiatives.