Supplier Quality Engineer 2

1 month ago

Addison, United States Acumed LLC Full time
Acumed LLC

Come join a team where People make the differenceAs a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

Job Scope:

The Supplier Quality Engineer 2 (SQE 2) will participate in all aspects of the supplier quality program, including participating in audits of suppliers manufacturing plants and sites to ensure compliance to Acumed and ISO 13485 standards and FDA regulations. The SQE 2 will assist/lead to determine that processes are performed and documented accurately, timely and in compliance with SOPs, cGMPs and FDA requirements in an ISO 13485 environment.

Responsibilities:

Serves as a Supplier Quality representative to guide efforts on small assigned product development teams ensuring compliance with Acumed policies and global regulations, including FDA Quality System Regulation and ISO 13485. Participate in plans to improve performance of business-critical suppliers, which may include directing efforts to resolve recurring supply chain issues involving quality & delivery. Leads/Participates in supplier Site Audits. Conduct and confirm follow up actions from supplier quality system audits. Assist with suppliers that do not meet required levels, assist Supplier Corrective Action Reports (SCAR) or other performance improvement initiatives and ensure these are being completed as planned. Participate in New Product Development teams for qualifying new supply sources: this encompasses raw materials, components, sub-assemblies, assemblies, and service suppliers. Maintain monthly tracking matrix and provide to management. Participates on small/medium special project teams to provide guidance with assistance for new supplier requirements. May supervise or mentor other Supplier Quality Engineers or contractors. Identifies changes in regulation and impact to the Quality Management System, specifically with Supplier requirements. Engages in continuous improvement activities by identifying opportunities and recommending improvements to design, manufacturing, or validation process. May provide training, guidance, and interpretation on regulations, procedures, and requirements. Communicates effectively and influences key stakeholders. Ownership of multiple programs within the QMS.

Qualifications:

Bachelor’s degree in an engineering or science discipline. 2+ years of experience in quality assurance in a regulated environment. If not degreed requires 8 years of experience in quality assurance in a regulated environment. Direct experience working with implantable devices preferred. 2+ years of experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.). ISO 13485 Lead Auditor Credentials preferred. Experience of working to International Organization for Standardization (ISO) 13485 standards and conducting audits Highly effective communicator. Able to facilitate difficult conversations and negotiate solutions among different department representatives.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to , and please be sure to include the title and the location of the position for which you are applying.

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