1+ months

Quality Manager - Medical Device

Kelly Services
Lexington, MA 02421
Quality Manager

Lexington, MA (with up to 25% travel)

Monday Friday, 8:30am 5pm

Kelly Scientific has an incredible opportunity for an experienced Quality Manager with a national Medical Device company at their corporate headquarters in Lexington, MA.

Day-to-day Responsibilities:

+ Manage and maintain full compliance to all applicable U.S. FDA Medical Device Regulatory requirements, ISO 13485, and all other applicable laws, regulations, and standards

+ Manage, train, develop, and oversee the Quality Management System department staff

+ Manage the department to optimize maximum productivity and compliance

+ Ensure that metrics and trends meet the department goals and objectives

+ Collaborate with other Corporate business sites and entities to achieve department goals and objectives

+ Perform Quality Management System activities, including but not limited to: Complaint processing, Supplier Management, Nonconformances, Equipment Management, CAPA, and Statistical Analysis

+ Attend all department and company-wide team meetings

You are an excellent fit if you meet the following requirements:

+ Associates Degree

+ 3+ years experience as a Quality Manager in a regulated Medical Device company

+ 3+ years experience of hands-on Quality Management System activities within a U.S. FDA and ISO 13485 regulated environment

+ In-depth knowledge of the following regulations and standards: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807, ISO 13485, ISO 9001, ISO 14971, and IEC 62304

+ Excellent leadership, communication, collaboration, team-work, and interpersonal skills

+ Demonstrated ability to effectively communicate with staff and business partners at all levels of the organization

This is a direct hire position, Monday Friday 8:30am 5pm, in Lexington, MA. Travel will be required up to 25% of the time. Pay starts at $100k plus 10% annual bonus, based on qualifications.

If you meet the above qualifications and are interested in being considered for the role, please apply immediately for consideration!

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-07-10 Expires: 2019-09-09

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Quality Manager - Medical Device

Kelly Services
Lexington, MA 02421

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