Manager, Quality Assurance

Posting Date 3 days ago(9/22/2022 4:15 PM)
Requisition ID
2022-11569
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Research Inc.
Category
Quality

Overview

This position manages the day-to-day resources and provides leadership and strategic direction for the CRI Quality Assurance team in order to achieve Cook global business needs.

Responsibilities

• Assign inspections, quality reviews, audits, and any other quality oversight activities, ensure timely completion while managing stakeholder priorities

• Develop and implement Quality Assurance process improvements

• Encourage and foster employee development through mentorship and training

• Provide leadership in accordance with company policies, procedures, applicable laws and regulations that apply to your business activities

• Ensure quality system activities, such as CAPA, audits, and change orders, are executed, documented, and completed

• Collaborate with other CRI teams to continually improve the Quality Management System that meet the requirements of the QMS, regulations, and standards

• Promote a culture of quality throughout the CRI organization

• Ensure quality oversight is executed to meet the requirements of the QMS and to be compliant to regulations and standards

• Work with HR to recruit, interview, select, hire and orient new employees

• Plan and allocate resources to effectively staff and accomplish work to meet functional and company expectations for productivity and quality goals

• Foster an environment where the giving and receiving of feedback is encouraged

• Facilitate the annual employee performance review process coordinated by HR.  Encourage employee contributions through goal setting, feedback and performance development planning

• Consult HR to document, administer and resolve employee disciplinary action if required

• Maintain ongoing communication with employees through team meetings, one-on-one meetings, email, and other appropriate forms of communication

• Review and approve employee requests through appropriate pathways and according to company policies (e.g. expense reports, purchase orders, PTO approval, education and tuition assistance hardware/software workflows)

• Establish trusted relationships with Cook colleagues, management, and external stakeholders by providing respectful, mindful and purposeful communication and maintaining a commitment to exceeding expectations

• Understand, practice and model the principles of honesty and integrity as outlined in the Cook Global Code of Conduct

Qualifications

• A minimum of a Bachelor's degree in a technical discipline

• Relevant experience working in Quality Assurance department, preferably in the medical device industry

• Experience must include: ISO 13485; ISO 17025; Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards; auditing; and MS Office Software (Word, Excel, Visio, PowerPoint, Project)

• Must have current authorization to be employed in the U.S. without employer sponsorship

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