Quality Engineer II - InHealth Technologies

Working at Freudenberg: We will wow your world!

Responsibilities:

• Reviews/ approves Design Control documentation (e.g. Design Verification, Process, or component validation)

• Leads Test Method validation activities associated with Design Verification activities

• Represents Quality in New Product Development (NPD) project team meetings & Design Reviews

• Prepares and releases Inspection Plans and Quality Control Inspection Criteria (QCICs) that supports qualification of purchased components

• Audits Design & Development activities to ensure compliance with procedures and standards

• Supports Risk Management activities for new or legacy products. This includes Risk Management Planning (RMP), Risk Analysis including post-market risk assessments, create Risk Management Reports

• Leads complaint investigations and trend reporting for InHealth Technologies (IHT) products

• Analyze internal and external quality product performance trends and address non-conformities

• Represent Quality engineering in Engineering Change Order process for IHT products

• Participates in both Internal and/or External audits

• Participates in any product recalls or field actions

Qualifications:

• Bachelor’s degree in Engineering, Sciences or related discipline

• Thorough Quality Management training for medical devices (FDA, MDR related)

• 3 + years demonstrated experience with corrective and preventive actions including formal problem-solving methodologies, critical thinking, and deductive skills

• Statistics and statistical analysis software (e.g. Minitab)

• Risk Management for Medical Devices (ISO 14971:2019) – knowledgeable in all aspects of risk management processes, including post-market risk assessments related to complaint processing

• Ability to create post-market surveillance and useability reports

• Well versed in working with Quality Management Systems (21CFR 820 Quality System Regulation and ISO 13485 Quality Management System for Medical Devices)

• Experience with GD&T and fixturing is preferred

• Experience with Medical Device Directive 93/42/EC and Medical Device Regulation (MDR) 2017/745

• Independent and self-direction coupled with a strong desire to work collaboratively as part of a high-performing team

• Outstanding written and verbal communication skills

• Profound experience in customer interactions regarding complaint resolution

• Keen ability to prioritize work and execute

• Strong organizational skills; strong technical/ computer skills

• This position does require occasional travel of up to 10%

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.

Freudenberg Medical LLC