Full-Time Manager, Divisional Quality,
Job Description
DESCRIPTION OF DUTIES
The Manager, Divisional Quality, will manage the divisional internal audit system to ensure overall QMS compliance with applicable regulatory and statutory requirements. You will coordinate and support third party regulatory inspections (FDA, Notified Body) and act as point of contact for Divisional External Manufacturers.
Responsibilities:
● Manage the divisional internal audit system to ensure overall QMS compliance with applicable regulatory and statutory requirements
● Coordinate and support third party regulatory inspections (FDA, Notified Body)
● Oversee internal QMS audits plan to the QSR (21 CFR Part 820), ISO 13485, European Medical Device Directive, Canadian Medical Device Regulations (CMDR) and other applicable Standards to ensure regulatory compliance
● Influence other groups to ensure development and implementation of corrective/preventive actions
● Work with others to identify areas of opportunity and support the continual improvement of the Quality Management System
● Organize and coordinate the logistics for third party inspections, as well as Divisional “audit readiness”
● Oversee performance of team members, including delivery of performance feedback and periodic performance reviews
● Work with the Process Excellence team to develop internal audit metrics and reports for Divisional Management Review activities
● Coordinate Management Review activities and Management responsibilities periodic assessments
● Perform initial due diligence for new product introductions with OEM (Original Equipment Manufacturer) and follow up on closing identified gaps
● Organize a team to develop and negotiate OEM and inter-plant Quality agreements.
MUST-HAVES
● 5+ yr exp Internal/External audits & 1+ yr mgmt direct reports – med device
● Bachelors in scientific discipline, pref. Masters or equivalent coursework
● Internal or Lead Auditor certification (CQA/CQE)
● Knowledge: QSR (21 CFR Part 820)/ISO 13485/EU Medical Device Directive/CMDR
● Exp w/4-D problem solving & facilitating work groups
NICE-TO-HAVES
● Experience in Six Sigma/Lead tools
● Experience interacting with regulatory agencies and Notified Bodies
● Experience in integration of quality management systems
CULTURE AND PERKS
Fortune, Glassdoor and Medreps have all named our company one of the top 20 employers in the country in 2015! We spend over $650 million dollars annually on research & development.
The Manager, Divisional Quality, will lead a team of two experienced individuals and be involved with all stages of audits. The ideal candidate will also be able to demonstrate the following:
● Work effectively with cross functional & multidisciplinary groups to assure conformance to regulatory requirements, and internal processes and procedures.
● Lead and influence without authority ability
● Achieve objectives with minimum supervision
● Coach, mentor, and counsel associates in regulations and standards
● Prioritize tasks in a deadline-driven environment
● Manage complex projects
● Work with external manufacturers and suppliers
● Negotiate and understand Quality Agreements
● Strong written and verbal communications skills
● PC proficiency in relevant Microsoft Office Suite applications.
Our client is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. We offer a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.
In addition to skills and expertise, the company assesses candidates on the following five key areas:
● Thought process
● Work style
● Relationships
● Motivation
● Influence
A note about visa sponsorship: The employer requires employees to work with the company for at least 1 year before sponsoring for green cards. Should a candidate have less than one year before they are applying for their green card, they will NOT be considered.
How to Apply
Please apply here: Https://www.ikrut.com/microsite/Microsite.ashx?job_id=30846&cmp_uid=8d0ef24a-6a12-4d01-ab94-54a2858c0f3d&strSourceID=32203&msite=True467 total views, 1 today