Quality Specialist

Job Summary:

The Quality Specialist will work closely with Management and the Operations team at the company headquarters located in the Westmoreland Business and Research Park, Upper Burrell Township, PA. They will be involved in maintaining a “Current Good Manufacturing Practice” (cGMP) compliant Quality Management System for a Medical Device manufacturer's implemented systems, processes, equipment and materials compliance to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, MDR 2017/745, and ISO 13485 requirements.

Primary Responsibilities:

· Support Quality Management Systems Operations within the organization

· Track, document, and report any changes in, or improvements to, the Quality System

· Involvement in quality processes, products, device history records, inspection, and personnel in all production areas regularly to ensure compliance

· Perform trend analysis on production and field data

· Investigate and document any problems relating to the product, process, or Quality System

· Initiate, recommend, and provide solutions to quality system

· Create or modify existing procedures used in the production facility

· Create and track change notifications on changes made to the system

· Inform and influence workers on improvements and corrections

· Participate in audits from the Food and Drug Administration (FDA), CE, and Xodus customers

· Participate in internal auditing practices

· Other Quality System related duties as assigned by Management

Requirements:

· Four year bachelor’s degree from an accredited university

· Preferred minimum of 2 years of experience in a regulated medical device setting with working knowledge of FDA 21 CFR Part 820 and ISO 13485

· Required Computer Software Skills: Microsoft Office Word, Excel, PowerPoint

· Good verbal and written skills

· Ability to work in a fast-paced environment with the ability to manage multiple, simultaneous responsibilities.

· Additional skills: Process Improvement, Analyzing Information, Attention to Detail, Thoroughness, Dealing with complexity and controversy

To Apply:

· Submit a type-written resume and cover letter to Paul Lloyd by email at PLloyd@XodusMedical.com

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Office

Experience:

• Quality: 2 years (Preferred)

Ability to Commute:

• New Kensington, PA 15068 (Required)

Ability to Relocate:

• New Kensington, PA 15068: Relocate before starting work (Required)

Work Location: In person