Job Title: Quality ManagerJob DescriptionWe are seeking a dedicated Quality Manager to lead and coordinate regulatory filings, manage quality assurance processes, and provide strategic regulatory advice. This role involves preparing and maintaining technical documentation and ensuring compliance with regulatory standards in the US and international markets.Responsibilities
Serve as the appointed Management Representative.
Lead, coordinate, author, and review regulatory filing documents.
Prepare US FDA submissions and compile technical documentation files, including 510(k) submissions, Device Master files, technical files, and post-market surveillance for product changes and new products.
Collect documentation and coordinate with cross-functional teams to prepare regulatory submissions to regulatory agencies.
Create and maintain regulatory submission timelines and track deliverables to ensure company goals are met.
Develop and execute the company’s regulatory strategy in the US, EU, Canada, and other international markets.
Provide strategic input and regulatory advice to project teams and development programs, including new product development and changes to existing products.
Stay current with the global regulatory landscape for medical devices, including FDA guidance documents and EU MDR.
Develop and communicate recommendations regarding new/emerging regulations to management and project teams.
Represent the company and work directly with regulatory authorities on regulatory issues and submissions.
Provide in-house training on quality and regulatory-related issues.
Support international RA and QA efforts and collaborate with other teams as needed.
Manage and modify a comprehensive quality management system for class I, II, and higher medical devices.
Review quality system processes to improve awareness, visibility, and communication on quality initiatives.
Conduct onsite audits and host regulatory agency audits as needed.
Evaluate, author, and review SOPs, forms, work instructions, etc.
Handle customer-related quality issues.
Establish and maintain an import and export compliance program.
Assist Marketing with trade show-related shipping and receiving tasks.
Direct and assign tasks to Quality, Shipping, Receiving, Warehouse, and Repairs personnel.
Recommend and implement measures to motivate employees to improve operations, equipment performance, product quality, and efficiency.
Recommend personnel actions such as hiring, promotions, firings, evaluations, and conflict resolution.
Perform physical inventory checks with Purchasing.
Observe and monitor gauges, dials, and other indicators to ensure that operators conform to SOPs.
Perform all aspects of building management, including safety and sanitation regulations.
Maintain commitment to Quality Goals and Quality Policy.
Complete jobs and tasks as assigned.
Essential Skills
Quality assurance
Audit
Medical device experience
5+ years of experience in the field
Knowledge of FDA regulations and experience with FDA submissions
Experience with internal and external audits
Root cause analysis
Quality management
ISO 9001 knowledge
Corrective action plans
Additional Skills & Qualifications
Proficient in all Microsoft Office applications (Word, Excel, Outlook)
Bachelor's degree or equivalent
Experience with ISO 13485
BONUS: EU-MDR knowledge
Experience with external audits
Work EnvironmentThis role operates in an ISO 13485 cleanroom. Employees have the opportunity to apply for a Work-From-Home program after three months, allowing them to work remotely one day a week. The company has a small, close-knit culture with approximately 30 employees. The workspace is currently being remodeled to enhance the working environment.Pay and BenefitsThe pay range for this position is $40.00 - $53.00Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)Workplace TypeThis is a fully onsite position in Emerson,NJ.Application DeadlineThis position will be accepting applications until Jan 31, 2025.About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
