Quality Manager - Medical Device Job Emerson New Jersey USA,Science

Location: Emerson

Location:

gSource, 19 Bland St, Emerson, NJ 07630, USA

Essential Responsibilities

Appointed Management Representative

Lead, coordinate, author and review regulatory filing documents

Prepare US FDA submissions and CE Mark technical documentation files, including 510(k) submissions, Device Master files, technical files and post market surveillance for product changes and/or new products as required to ensure timely clearance or approvals

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 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

Keep abreast of current regulatory landscape for medical devices globally, e.g., FDA guidance documents, EU MDR, EU guidance documents, etc.

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/regulatory related issues

Support international RA and QA efforts and collaborate with other teams across the company as needed

Manage and modify a complete and 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 to support assigned quality goals and objectives

Conduct onsite audits and host regulatory agency audits as needed

Evaluate, author and review SOPs, Forms, Work Instructions, etc.

Handle customer related quality issues

Non‑Essential Responsibilities

Prioritize daily tasks resulting in “on-time” processing

Establish and maintain an import and export compliance program

Assist Marketing with trade show related shipping/receiving tasks

Direct and assign tasks to Quality/Shipping/Receiving/Warehouse/Repairs personnel

Recommend and implement measures to motivate employees to improve operation methods, equipment performance, product quality or efficiency

Recommend personnel actions such as hiring, promotions, firings, evaluations and conflicts

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

Qualifications

Education:

Bachelor degree or equivalent, previous experience preferred
Language skills:
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents; respond to inquiries from customers, regulatory agencies, or the business community; write speeches and articles for publication; present information to top management, public groups, and/or boards of directors
Reasoning ability:
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists, and to interpret instructions furnished in written, oral, diagram, or schedule form
Computer skills:
Proficient in all Microsoft Office applications (Word, Excel, Outlook)
Physical demands:
Occasionally required to stand, walk, sit; vision abilities required to adjust focus
Work environment:
Noise level is usually moderate

Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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