Quality Manager

Description

Company Overview: 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 the Biomerics values in all our interactions. It is an exciting time to be part of our collective team. There is no limit to the impact that can be achieved here at Biomerics. We improve and advance our employees' and patients' lives that depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships with customers and our team members.

General Summary – Maintain the Quality System and direct the activities of the Quality Department. This employee is also the Management Representative for ISO 13485 certification. This position reports to the Director of Quality (California), and the site reports to the President (North Carolina). On-site job, not remote. 

Description of Responsibilities

• Management Representative for ISO 13485 certification. 
• Maintain the QMS for the Biomerics Mebane, NC, and Dominican Republic sites.
• Participate in the Leadership Team in Mebane, NC, and the Dominican Republic sites and organize all efforts across the quality functions where applicable.
• Maintain headcount and budget across the Quality Department. 
• Define and document how the requirements for quality will be met, including preparing quality plans and identifying resources needed to fill that plan.
• Conduct Management Review meetings as scheduled by the procedure.
• Communicate cross-functionally with Ops, Engineering, and where appropriate. 
• Establish and maintain good regulatory standing with state, federal, and international regulatory agencies.
• Oversee staffing needs for the quality function.
• Ensure that quality and regulatory requirements are integrated into the launch of new products.
• Establish and maintain documented procedures to control all documents and data related to applicable standards.
• Assure that customers’ needs are met.
• Gather information and seek out and identify opportunities and business process definitions by defining and documenting processes and procedures. 
• Guide process quality and compliance. 
• Manage customer expectations and timelines for products and projects. 
• Assemble metrics, presentation, and goal setting for the department. 
• Conduct yearly competency reviews for all applicable resources.
• Initiate and manage all applicable CIPs (Continuous Improvement Projects) for the Quality team. 
• Manage direct reports across Quality Systems (training, documentation, calibration) and Quality Engineering (Tech Transfer, production line, projects). Quality Control where applicable. 
• Manage Non-Conformance and CAPA workloads and metrics by managing the Quality Engineers/Cross-functional teams. 
• Function as lead/organizer or delegate where appropriate for any supplier, customer, or regulatory audits.

Requirements

Minimum Educational Requirements (must have ONE of the following)

• Master’s (or equivalent degree) and 2-3 years of relevant work experience, or
• Bachelor’s degree and 4 years of relevant work experience, or
• Relevant comparable background and 10 years of relevant experience.
• Work experience is in knowledge management or process improvement in the pharmaceutical, medical device, or related healthcare industry.

In-depth knowledge in the following areas:

• Quality regulations and guidance (for example, ISO, EU Directives, ICH guidelines, and other industry standards).
• Quality Management System Documentation (including document control) and Training best practices.
• Process management and Knowledge management techniques.
• Relevant scientific education and knowledge to provide quality assurance oversight for quality activities and understand specific activities, including technical writing, training development and deployment, and continual process improvement methodologies, including root cause analysis and appropriate methods (e.g., Lean, Six Sigma, etc.).
• Risk management principles and process.
• Fundamental base-level understanding of finance as it relates to the production and manufacturing of medical devices. 
• Change management.
• Communications: professional, clear, concise, and consistent verbally and in writing to internal and external customers.
• Must organize and prioritize work effectively to meet timelines with quality deliverables.
• Must be able to work independently and in a collaborative team setting.

Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 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 from Biomeric's salary range. 

Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Biomerics approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics, and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.

Salary : $97,600 - $124,000