|Title:||Vice President of Quality and Regulatory Affairs|
|Location:||Colorado Springs, CO|
This position is responsible for the overall leadership and execution of the quality assurance and quality control strategy, programs and policies across all of NMT’s Medical Device Manufacturing sites. As a member of the company’s Quality Leadership Team, the successful candidate will lead the development, articulation, implementation and continuous improvement of Global Quality projects, policies and compliance programs. Acts as a champion for building a “culture of quality” across the organization.
This position is responsible for ensuring compliance of medical devices to FDA, EU, ISO, and other international requirements to ensure compliance across multiple manufacturing facilities. This position will advise on and coordinate the approval and registration of medical devices, being a crucial link between the company, its products and regulatory authorities including the FDA, CMDCAS, EU Competent Authority, ISO registrar and applicable international authorities.
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
- Demonstrate knowledge and act in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
- Identify and drive continuous improvement of quality procedures and compliance projects at all manufacturing sites ensuring harmonization, simplification and globalization. All processes and products must meet high internal standards and regulatory requirements and ultimately deliver high-quality, cost-effective products to the customer.
- Develop, implement and communicate a clear strategic vision for site quality to maximize employee alignment and engagement, and performance.
- Maintain a strong independent role as it relates to compliance-related decisions.
- Provide technical direction and support with respect to all aspects of the Company’s business compliance activities, and that the Company’s existing system of quality data collection, metrics analysis, trending and report generation is current, thorough, and enforced through site SOPs.
- Responsible for ensuring that all Quality systems across all Global Manufacturing sites are in full compliance with regulatory requirements and are aligned with Corporate Quality policies and programs.
- Ensure that all QA responsibilities including training, internal audits, investigations, complaints, CAPAs, change control, document control, incoming inspection and manufacturing oversight, are implemented and maintained across all manufacturing sites in compliance with all Corporate Quality policies and programs.
- Responsible for sites compliance with on time delivery of all commitments and CAPAs to drive compliance excellence and enhancement year over year.
- Ensure compliance of Site SOPs with Global Policies and SOPs.
- Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities. Ensure that performance issues are managed in a consistent and timely manner.
- Develop departmental expense, capital budgets and headcount projections. Track and manage expenditures and headcount to budget over the fiscal year.
- Escalate key product issues and critical quality system failures to Executive Management.
- Authorized to act as the company’s representative during FDA and other regulatory agency investigations relating to cGMP inspections, customer compliant follow ups, etc.
- Lead initiatives to harmonize systems across manufacturing sites (Manufacturing, Supplier Quality, corporate QA, etc.) where appropriate.
- Establish and actively maintain internal/external customer service relationships in accordance with corporate shared values. Work with corporate and/or industry groups to share and implement best practices.
- Foster an environment of collaboration, trust, quality, innovation and continuous improvement within the Company and between functional departments.
- Lead change in the organization to continuously adapt to a dynamic business environment; apply learning to enhance organizational performance.
- Establish and implement periodic monitoring and evaluation programs to effectively assess compliance of processes that are in place.
- Proactively identify issues, concerns or any potential or significant risks to the business and ensure that appropriate preventative actions are in place at all sites.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Manages Regulatory approvals with FDA, Health Canada, Notified Bodies, EU Competent Authorities, EU Representative and international authorities.
- Conduct regulatory intelligence monitoring activities and advise management accordingly.
- Prepare global regulatory approval submissions.
- Ensure product labeling meets regulatory requirements.
- Other duties as assigned.
- Travel is required.
- Bachelor’s Degree from a four-year College or University in a related discipline. Master’s Degree preferred.
- 10+ years’ experience in the medical device field.
- Previous experience in a Senior Quality Management function in a global organization.
- Strong knowledge of GMP/GDP in both domestic and international regulatory environments, specifically the FDA.
- Demonstrated proficiency in leading cross functional groups to conclusions.
- Strong understanding of medical device labeling requirements.
- Acute attention to detail. Demonstrated ability to plan and organize projects.
- Proficient on Microsoft Office product (Word, Excel, Access and PowerPoint).
- Prior experience with FDA establishment registration, device listing, 510(k) or PMA submissions and prior experience with international submissions.
- An established leader with demonstrated ability to lead change and implement sustainable Quality Systems in support of a complex operation.
- Ability to motivate and energize the team for quality improvement through strong interpersonal and leadership skills.
- Ability to make tough decisions to enhance organizational skills
- Demonstrated ability to work effectively in a global matrix organization.
Commitment to excellence and high standards. Versatility, flexibility, and willingness to work with constantly changing priorities with enthusiasm.
- Excellent written and oral communication skills.
- Ability to work with all levels of management.
Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call (719) 426-9074.
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