Document Control / Manufacturing Support

Job Description

Job Description

Exceleron Medical is an FDA registered, ISO 13485 certified Medical Device manufacturer. We are committed to raising the bar of performance across everything we do; our technologies and products as well as our processes. As a leading manufacturer of respiratory filtration products in the United States, Exceleron Medical is seeking to add a critical individual to our team. With our recently FDA Cleared, Patented, Heated CPAP Tubing, we are poised for tremendous growth in sales and manufacturing in an ever-growing space. This recent approval also launches us into an exciting space of additional heated tubing opportunities as well as other Device opportunities. We are looking for a motivated individual who is driven and motivated to grow in their career and on a personal level. We offer an exciting, friendly, positive and fun atmosphere. This is an excellent opportunity for career advancement and learning. Below is the experience we are looking for in the DOCUMENT CONTROL position:

Location: Saint Paul, MN

Job Summary: The Document Control/Manufacturing support will support the FDA/ISO 13485 Compliant quality system and also support various medical device manufacturing operations. This role involves wearing multiple hats, including assisting in the maintenance and improvement of the quality management system (QMS), documenting compliance with regulatory requirements, personnel training and assisting in the support of manufacturing equipment as needed.

Key Responsibilities:

· Comply with all quality requirements related to FDA:21CFR Part 820, ISO 13485 and internal Standard Operating Procedures, Work Instructions, and Guidance Documents.

· Conduct QMS audits and prepare audit reports to identify quality issues and trends.

· Conduct incoming inspections and purchase order receipts in the manufacturing ERP system.

· Personnel training from the Quality Assurance system perspective, ensuring all associates are properly trained to the QMS.

· Assign lot numbers to production batches (this is a critical area of the position).

· Troubleshoot and help set up and support manufacturing equipment including sonic welders, glue machines, rotary tables.

· Lead root cause analysis for product non-conformances and develop corrective actions.

· Document QMS improvements through implementing and managing Corrective Actions as assigned.

· Manage validation and qualification processes for new and existing products.

· Review and approve product documentation, including validation protocols, inspection and release records.

· Maintain and document equipment calibration and maintenance.

· Assist in supplier qualification and monitoring activities to ensure regulatory compliance and product conformity.

· Perform and document inspections of incoming purchased products.

· Develop and maintain work instructions, BOM's and procedures through the change control process.

· Create change control documentation and obtain approvals for changes to QMS documentation.

· Maintain paper and electronic controlled QMS documents and records.

· Maintain training assignments and records.

· Assist with investigation and documentation of customer feedback and complaints.

· Other duties as assigned to contribute to the achievement of department and corporate goals.

· Train manufacturing personnel on work instructions and manufacturing processes.

· Document nonconforming materials on the production floor and assist as necessary in efforts to quarantine products and components and identify appropriate disposition for components and assemblies.

· Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.

· Comply with equipment calibration and maintenance SOPs, assist as needed with equipment calibration and preventive maintenance programs.

Qualifications: EXCELERON WILL PROVIDE TRAINING FOR FDA AND ISO QUALITY REQUIREMENTS

· Bachelor’s degree, 2 years Quality Assurance, or related field preferred.

· 2+ years of experience in quality assurance/doc control or related experience within the medical device industry preferred.

· Good understanding of FDA and ISO regulations preferred, especially ISO 13485 (again, Exceleron will provide training for this role).

· Experience with quality auditing.

· Good problem-solving, organizational, and communication skills.

· Experience with ISO 13485 and FDA audits preferred (Exceleron will provide training in this area).

· Able to oversee ISO 13485 Quality System and its management

· Able to communicating Corporate Quality Objectives to Management

· Proficient in internal audits and training

· Familiar with identifying and managing Corrective and Preventive Actions

Preferred Skills:

• Experience with medical device manufacturing.
• Familiarity with Lean Six Sigma or continuous improvement methodologies.

Pay Range:

• $25 - $30 / hour
• This is not a remote position.