Quality Engineer

Since 1969, Creative Foam has designed and manufactured cellular and non-cellular foams and plastics for our automotive customers. Key ingredients in our success in this market include innovative people, an abiding passion for quality and an unwavering commitment to the customer. Find your home at Creative Foam!

Competitive Benefits & Compensation Package

• Safe working environments

• World class benefits

• Medical, dental, vision plans and flexible spending accounts

• Company paid short term disability, long term disability, and AD&D insurance

• 401k with employer match

• Generous holiday and vacation allotments

• Dependent scholarship program

• Wellness program

• Referral program

Pay

Pay commensurate with education and experience.

Creative Foam wants to be a great service provider to our customers. We recognize we can only do that if we are a great employer. Our success is driven by the success of our employees.

Our culture focuses on three core values:

• Be Inclusive- Make a difference as a TEAM, work collaboratively and support others in our effort to greatness. Constantly strive for perfection and quickly learn from our mistakes.

• Be Inventive-Never stop learning and push the TEAM to strive towards sustained excellence. Aim to provide our customers with the most creative solutions in the market.

• Be Responsible-Maintain an equitable relationship with our customers, employees, stakeholders and communities as we develop as a TEAM.

• Be Relentless-Demand more from yourself and the TEAM than you think is imaginable, this will drive change and only then will we achieve our goals.

#WelcomeHomeToCreativeFoam

Position Objective:

Provide quality and regulatory support to the operations teams, specifically as it relates to ISO 13485:2016 and FDA and, ultimately, the Creative Foam QMS.  Provide direction, training, and guidance to the Bremen team. Assist management in making sound decisions through the collection, organization, and presentation of data. Collaborate with Process Engineering and Operations, as needed, in the process flow, process validation, continuous improvement, and problem-solving projects.

Primary Responsibilities:

• Develop and implement ISO 13458:2016 quality standards.

• Develop and implement quality control systems.

• Monitor and analyze quality performance throughout multiple Bremen areas.

• Manage internal audits as Lead Auditor.

• Inspect and test materials, equipment, processes, and products to ensure quality specifications are met.

• Collaborate with Engineering and Management to develop and implement controls and improvements.

• Ensure that workflows, processes, and products comply with quality and safety regulations.

• Investigate and troubleshoot product or production issues.

• Develop corrective actions, solutions, and improvements.

• Review codes, specifications, and processes.

• Provide training and education to facility employees regarding the Quality Management System.

• Support verification and validation efforts.

Competencies Required for Position

Communication

Highly effective written and verbal communication with coworkers, contractors, vendors, and clients.

Teamwork

Be able to work as a “Team” with fellow associates, vendors, accounting professionals, and clients.

Problem-solving

Be able to identify problems independently, try out, and implement solutions with minimal direction.

Planning and Organization

Must be able to prioritize and work on multiple projects at the same time.  Pay attention to detail.

Learning

Must be able and motivated to learn quickly on the job, curious to learn new things, and strive for continuous improvement.

Qualifications/Knowledge/Experience

Successful candidates will have a stable work history, excellent attendance, and reliable transportation. Applicants will be required to undergo an interview, drug testing, and a criminal background check.

Qualifications – (Desirable):

• Four-year technical degree in quality, industrial, mechanical engineering or equivalent.

• 2+ years of experience in quality engineering, quality assurance, or a similar role.

Knowledge, Skills & Experience (Essential):

• ISO QMS standards, preferably 13485:2016

• Experience working in a manufacturing environment, interacting with internal and external multidisciplinary teams.

• Blueprint layout and reading.

• General computer skills; MS Office, internet, email

Knowledge, Skills & Experience (Desirable):

• 21CFR820

• EU MDR

• Bi-lingual; English and Spanish a plus

• Lead Auditor Trained

• ASQ certification a plus.

• Experience coding and using QA software tools and processes.

Occupational Health and Safety

Employees are responsible and accountable for:

• Compliance with workplace policies and procedures.

• Active participation in activities associated with the management of workplace health and safety.

• Identification and reporting of health and safety risks, accidents, incidents, injuries and property damage at the workplace.

• Correct utilization of appropriate personal protective equipment.