Competitive salary, full benefits and great company culture!!
Long term disability/Life insurance
Sick and vacation leave
Solmetex, LLC has a unique and exciting opportunity for a Manager of Quality & Regulatory Compliance. Solmetex is an industry leader in dental waste management solutions and is growing rapidly through recent acquisitions of FDA and EPA regulated product lines. Solmetex is seeking an experienced leader who will be primarily responsible for establishing and maintaining a Medical Device Quality Management System to the requirements of US-FDA & EPA, EU, UKCA/MHRA, and Canadian regulatory requirements. This position will have broad quality and regulatory compliance responsibilities across all products of Solmetex, to include the recently acquired Sterisil and DryShield portfolio of products.
Key Job Responsibilities:
Develop and maintain quality and regulatory compliance process ensuring compliance with regulatory and ISO requirements.
Assess compliance, status and effectiveness of management teams and related quality and operational systems.
Keep management informed of any critical issues and or corrective actions that may impact the operations.
Facilitate management review meetings and report quality metrics for Quality Management Review
Provide updates to upper management as required for quality related matters
Ability to establish, build and maintain professional working relationships with all levels of staff, FDA and third party
Participate in Regulatory Affairs activities for all current and future medical device products
Monitor current standards, regulations and guidelines and ensure that all employees are informed as to changing requirements
Ensure continued compliance with revised standards, regulations and guidelines
Lead company-wide efforts to achieve ISO 13485:2016 certification needed for EU market entry
Oversee the project plan to meet UDI and GUDID requirements
Champion the assessment of the current QMS & eQMS systems and develop the plan for a single, consolidated enterprise approach
Qualifications / Requirements:
Bachelor’s degree in Life Sciences or Engineering
Minimum 5-7 years QA management, experience in medical devices
Experience in all aspects of Quality Assurance (21 CFR Part 820, ISO 13485, auditing, ISO assessments, FDA inspections etc.)
Must have previous experience interacting with ISO, FDA and other regulatory agencies
Ability to interpret regulations, standards and guidance documents and implement requirements
ISO 13485 and ASQ certification a plus
Must have excellent written and verbal communication skills
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
Is dedicated to meeting expectations and requirements of internal and external customers
Excellent interpersonal, verbal and written communication skills Meticulous attention to detail and meeting deadlines
Demonstrates accuracy and thoroughness and monitors own work to ensure quality
Self-starter with can-do attitude to strive quality excellence in a fast paste start up environment
Broad knowledge of FDA rules and regulations as they relate to medical device manufacturing
Solmetex is a smaller company with around 50-100 employees. We are family-friendly, inclusive and have a great company culture.
In 1999, Solmetex designed the Hg5 Amalgam Separator which quickly became the gold standard in amalgam separation. Today, Solmetex is proud to be the industry leader and manufacturer of the NXT Hg5® series of Amalgam Separators and proud to celebrate 25+ years in the industry. Our comprehensive product line provides all the necessary components to meet or exceed the current requirements of the EPA “Dental Rule”.