Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation 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-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.
The Quality Manager - Transfers is part of the manufacturing transfer team and is responsible for supporting manufacturing line transfers within Biomerics and from external customers to Biomerics sites. This position reports to VP, Quality & Regulatory.
Responsibilities
1. Quality Planning – work with transfer teams to plan needed resources to complete project activities on-time and within budget. Negotiate QMS requirements and quality deliverables with customers at project initiation.
2. QMS Compliance – Ensure that transfer teams maintain compliance with QMS requirements and remove QMS roadblocks to ensure project success.
3. Customer Interface – Must be able to effectively communicate and negotiate with customers at various levels, including project teams and management. Excellent written and spoken Spanish and English required.
4. Issue Resolution - work with customer and Biomerics teams to resolve quality-related project roadblocks. Initial point of escalation for project teams regarding quality items.
5. Manage a wide variety of programs and improvement initiatives for specific projects and for the transfer process.
Desired Skills
1. Ability to apply ISO 13485 & 21 CFR 820 principles to QMS and project requirements
2. Manufacturing transfer experience
3. Root cause analysis
4. Understanding of statistical sampling, analysis, and design of experiments
5. Lean manufacturing
6. Six Sigma
7. Business acumen
8. Technical writing
9. Excellent verbal and written communication. English & Spanish required – C1 or C2 level (CEFR)
Qualifications
1. Bachelor’s degree in related engineering or technical field (Mechanical, Chemical, Material Science, Plastics, etc.)
2. Working understanding of ISO 13485, ISO 14971, ISO 17025, 21 CFR 820
3. Experience supporting or leading manufacturing transfer projects
4. Preferred: 7+ years related experience in the medical device field
Biomerics offers the following benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, 9 Paid Holidays, and 401k.
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