This role is required on-site in Bellingham, WA, and does not come with relocation assistance.
The Quality and Regulatory Compliance Engineer provides direction and support pursuant to assuring that both external product safety and regulatory requirements as well as internal process/Quality Management System (QMS) requirements are met.
Key Responsibilities
Regulatory Compliance
The ability to review, interpret, and apply various domestic and international regulatory standards to the design and performance of Wood Stone products:
UL 197
ANSI Z83.11
NSF 4
Various CE Mark directives (EMC, Low Voltage, Gas Appliance Regulation)
Other standards as they become relevant to Wood Stone products
Remain versed in changing regulatory requirements and share with stakeholders.
Minimize corporate exposure to risk associated with our products.
Ensure continued compliance with requirements set forth in standards.
Acquire new certification marks as required.
Support 3rd Party Listing Audits
CE – Annual Surveillance Audit
ETL – Quarterly Audits
Monitor electromechanical new product development and influence designs to assure standards compliance; resolve technical issues.
Assist in conducting and witnessing tests and evaluating failures.
Facilitate test plans and execution prior to Regulatory Agency listing testing to assure success.
Quality Assurance and QMS
Assists the Quality Manager in developing and implementing formal Wood Stone QMS.
Supervises QA Technician; assists in nonconforming materials disposition
Chairs the Material Review Board (MRB).
Works together with the Supply Chain Manager to monitor supplier quality.
Works together with the Technical Service department to evaluate field failure data and enact corrective/preventative actions (CAPA).
Drives CAPA to assure continual improvement; helps to investigate and determine root causes of problems, both internal and suppliers.
Develops inspection plans, failure analysis systems, and process control plans for new and legacy Wood Stone products.
General
Performs internal compliance and QMS audits.
Teaches, through presentations, the different aspects of Listing Marks to bring about a widespread understanding of the importance of Regulatory Compliance. Train Wood Stone personnel on elements of the Quality Management System and related procedures.
Provides resources and support for failure analysis for engineering, operations, and service teams.
Supports and promotes Wood Stone Continuous Process Improvement initiatives.
Performs other duties as assigned.
Key Qualifications
Bachelor of Science degree in Engineering or related field; or equivalent experience
5-7 years of experience in Regulatory Compliance (UL, ETL, CSA), product safety, and QA/Quality Management systems (ISO 9001, AS9100, FDA cGMP), including working closely with 3rd party auditors and inspectors.
Demonstrated understanding of the various regulatory agencies and requirements.
Working knowledge of continuous improvement methods and root cause analysis
Demonstrated communication and interpersonal skills and the ability to work in a highly cross-functional team environment; ability to engage with both technical and non-technical personnel in management and production areas.
Experience in a mechanical or electromechanical products manufacturing environment
Computer skills sufficient to generate and analyze data and generate reports. Statistical analysis software experience is a plus.
