Job Details

Design Quality Manager

Company name
Ecolab

Location
Alpharetta, GA

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Profile

Ecolab is a looking for a Design Quality Manager position in Alpharetta, GA to support the Global Healthcare Division. This position will partner with R&D and lead the design quality team in the product development process to meet business growth, risk management and operational objectives of the Global Healthcare Division of Ecolab. This position is responsible and accountable for compliance with global (FDA, EN/ISO, etc.) regulatory requirements, as well as company procedures and policies. This position is responsible specifically for the Quality System processes to support the commercialization of products for the Global Healthcare Division.

Role and Responsibilities

Design control and quality advocate for projects related to new and changed Healthcare products/ processes.

Subject Matter Expert (SME) with regard to design control and regulatory (FDA, ISO) compliance.

Oversee the management and maintenance of Design History Files and Device Master Records.

Manage and escalate design control process non-conformities

Track design corrective actions and follow-up on completion

Maintain system compliance with applicable regulations across multiple departments

Participate in external and internal audits as required and drive corrective actions in response to such audits.

Create design control process improvement initiatives that are effective and efficient to execute for internal customers.

Act as Management Representative for the Alpharetta site

Proactively manage and develop talent within design quality

Partner with manufacturing site quality to ensure effective design transfer of new products.

Basic Qualifications

Bachelor’s degree in technical field, including engineering, biology, microbiology or chemistry.

5 years combined experience in people management and project management

5 years’ experience working in a healthcare medical device regulated environment

5 years’ experience in managing design control and risk management in the medical device environment.

Preferred Qualifications

Familiarity with medical device manufacturing environments and quality systems required to meet regulations.

Excellent written and oral communication skills

Location:

Alpharetta, GA, US

Posted Date:

4/12/2018

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Company info

Ecolab
Website : http://www.ecolab.com/

Company Profile
Ecolab is the global leader in water, hygiene and energy technologies and services. Around the world businesses in foodservice, food processing, hospitality, healthcare, industrial, and oil and gas markets choose Ecolab products and services to keep their environment clean and safe, operate efficiently and achieve sustainability goals.

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