Full-time
Description
Company Overview
Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech indus-tries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-genera-tion solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.
At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to Biomerics' values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance the lives of our employees and the patients who depend on our products.
At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-fo-cused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.
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.
Other duties as assigned.
Requirements
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 helpful
If you believe that your skills and talents match our needs, please email your resume to . Be sure to include your name and the job position of interest.
Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, and 401k.
Please, No Recruitment Agency calls or emails (we are not using recruitment services for this or any other role posted).
The salary estimates are estimates from this job board and not a guarantee of Biomerics’ salary range.