|We are seeking a Quality Engineer to work in the Research and Development department. This position will work collaboratively with employees in both the R&D and chemical production departments. The ideal candidate will have to work cohesively in a strong team oriented environment to develop and improve processes and products for mass production.
Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures during product development.
Collaborate with the Regulatory department to help facilitate and implement successful design processes.
Prepare appropriate documentation as required by internal product development process and regulatory agencies such as FDA and ISO.
Provide expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques.
Facilitate Risk Management process in compliance to appropriate external standards and corporate policies.
Perform root cause analysis and implementation of corrective action for process related concerns.
Ensure Quality Engineering support of customer complaint investigations as required.
Prepare audit reports based on audit findings and follows up on corrective actions related to audit findings, nonconforming product, or overall supplier performance to ensure effective resolution and timely closure.
Participate in activities required to qualify suppliers and maintain for various levels of approval, such as preferred, dock to stock, and certified suppliers.
Assist in the development, approval, and maintenance of material specifications, vendor instructions, quality assurance procedures, as well as supplier documents such as Quality Control Plans.
Develop and maintain specifications & SOP's in area of responsibility.
Understands and is able to review quality records to verify information is correct and complete and that specifications have been met
Regularly monitor the production and machinery to ensure the quality.
Formulate quality control standards properly.
Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data.
Strong knowledge of regulations and regulatory requirements
Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and give oral presentations.
Must be able to identify and recommend effective solutions to problems, working individually and with others within and outside his/her function.
Working knowledge of GMP/QSR, ISO, Medical Device Directive, and other applicable regulations is expected.
Working knowledge of desktop computer, office software, and e-mail is required.
Ability to handle multiple tasks simultaneously and ability to manage project timelines.
Must be accurate in handling detailed information/data.
Strong writing skills, including composition and grammar, in order to draft effective supplier audit reports
Effective organizational and time management skills.
Excellent verbal and written communication skills.
Experience/Schooling or Degree Required:
Minimum BS Degree in Electrical Engineering or Computer Engineering
Experience in the medical device industry is preferred.
ASQ Certification preferred: Biomedical Auditor and Software Quality Engineer
2+ years experience in software lifecycle activities required, preferably in a regulated product development environment.
Formal training and experience in auditing required.
Experience participating in software verification activities and creating test documentation for medical devices preferred.
Familiarity with RoHS and EHS Guidelines preferred.
Experience with agency testing, e.g. UL, CSA, IEC, etc. preferred
State or Province