Company Description : Biomerics is a world class contract manufacturer and innovative polymer solutions provider for the medical device and biotech industries.
As a vertically integrated company, we specialize in the design, development, and production of medical devices for diagnostic and interventional procedures.
We are focused on next-generation solutions for the vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
Please explore our website for more information about our offerings and capabilities.Job Description : This position will be responsible for supporting our day-to-day compounding operations as well as identifying and implementing process improvements.
In addition, will provide leadership to a team of operators to ensure deliverables of the value stream are met.Roles and Responsibilities Include : - Troubleshoot and solve department issues as they occur.
- Manage existing production and new product scale ups.- Assist with development and implementation of Quality procedures, Standard Operating Procedures and other related documentation.
- Strong leadership skills and the ability to work with little or no supervision.- Perform all work within ISO 13485 and 9001 : 2000 documentation and quality standards.
- Interview new job applicants to backfill or increase the size of the work force when needed to meet production demand. Efficient use of labor / equipment and materials.
- Partner with process engineers to update Device History Records (DHRs) and Work Instructions (WIs) when necessary.- Train operators and ensure they follow detailed WIs, processes, and procedures to correctly produce products from the value stream.
- Partner with the quality, engineering, and maintenance departments to ensure problems with quality, processes, equipment, or materials are resolved correctly in a timely manner.
- Partner with New Product Engineering to successfully bring new products into the value stream.- Interact with customers to ensure their product development and production needs are met.
- Partner with shipping to ensure orders are delivered on time.- Oversee the scheduling, production, and inspection required per the value stream.
- Complete line clearance, scrap records, training records, DHRs, and other documentation as required.- Complete production reporting of work orders and cycle counting to ensure accuracy of inventory.
- Maintain a clean and organized work area to facilitate manufacturing functions.- Complete annual performance reviews for operators in area of responsibility.
- Comply with the policies, guidelines, and regulatory requirements of the Biomerics Quality System.- Must be able to lift 55+ lbs.
on a regular basis. - Comply with the policies, guidelines, and regulatory requirements of the Biomerics Quality System.
- Must be able to lift 55+ lbs. on a regular basis.- Other duties as assigned.RequirementsRequirements : - High school diploma or equivalent (Required).
- Bachelor's degree in a business or science discipline (Preferred).- 2 years of management experience.- Familiarity with ISO 13485 requirements.
- Excellent verbal and written communication skills.- Meticulous record-keeping capability.- Excellent prioritization and organizational skills.
- Ability to manage multiple responsibilities and personnel with little to no supervision.- High level of initiative and flexibility in adapting to changing needs of a dynamic work environment.
- Proficiency with Outlook, Word, PowerPoint, and Excel.- May be required to wear a respirator when performing select job duties.
- Spanish speaking is a plus- Some experience with ERP is helpfulIf you believe that your skills and talents match our needs, please email your resume to csr@biomerics.
com. Be sure to include your name and the job position of interest.Salary Description $73 - $80