Quality Assurance Engineer jobs in North Carolina

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Quality Assurance Engineer 2.

Job Description:

Job Title: Quality Assurance Engineer 2

Job Location: Chapel Hill, NC

Duration: 6 months
work Schedule: Onsite

Pay Rate: $90.25 - $95

Responsibilities:

Primary Function of Position:
This key role will be vital in establishing a quality system and strategy at our KindHeart division. This individual will be responsible for enabling the division to establish optimum quality control in product manufacturing through implementation of key quality metrics, leading the change control process, implementing actions to reduce defects and meet quality objectives. This role will coach, mentor, teach and influence the site on best quality practices and data based decisions. The ideal candidate will have experience with tissue-based products and a small team or start-up environment.
Roles and Responsibilities:
Lead development and implementation of quality management system, processes and metrics.
Ensure Operational execution meets industry standards, and country specific import regulations in coordination with Regulatory partners.
Handles Material review boards on a timely basis by tracking open Quality Notifications that affect assigned products.
Works with engineering in developing criteria for incoming and outgoing product quality and build mechanisms to assure quality assurance.
Reviews, approves and supports engineering studies and validation protocols related to product quality and product performance written and performed by Manufacturing Engineering.
Prepares trend reports of Quality Notifications and performs analysis of major offenders.
Quality Advocacy and Project Management
Lead and manage quality initiatives related to defect reduction, systems, new products.
Performs formal escalation process as required.
Evaluates deviations and non-conformances and supports a resolution of quality issues by a risk-based approach.
Leads Failure investigations and is a key player in process improvement activities.
Participates in the development of lines, process and/or product validations documenting their results
Conduct and review Process Risk Analysis, Supplier Process Risk Analysis, Process V&V, line qualifications
Performs mentoring activities for Quality Engineers and other Quality team members.
Provides feedback clarifying quality controversies to Manufacturing or Final Quality Inspection Technicians according to established quality and regulatory standards.
Participates in Customer Complaint investigations.
Participates in the development and preparation activities for Audits and support front room and back room as needed.
Drives our Culture and Strategy by fostering our mission, founding principles, individual and leadership expectations.
Comply with the Organization's Policies, Regulations and Code of Conduct.

Qualifications

Skill/Job Requirements:
Minimum Bachelor s degree in engineering or equivalent experience. Advanced degree preferred
Minimum 8 years of experience in Quality Engineering or related field
Deep knowledge of ISO standards (13485 or 9001) and application
Medical device industry experience preferred.
Knowledge in Tissue Manufacturing preferred in addition to Knowledge of Human and Animal anatomy.
Prior experience with APHIS compliance and registration as well as USDA Regulations preferred
Experience with diverse manufacturing processes e.g Manual assembly processes, synthetics, plastics molding, forming, assembly, etc.
Minimum 7 years of experience with validation, audits, CAPA
Excellent Project management skills, problem solving skills, written and verbal communication
Capable of thinking independently and making decisions based on limited information
Knowledge of Lean/6 Sigma/Root Cause analysis, Black Belt level preferred
Computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP. Minitab is a plus
Ability to read, interpret and communicate technical information
Ability to travel on an as needed basis domestic and international (up to 10%)

About Maxonic:

Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.

Interested in Applying?

Please apply with your most current resume. Feel free to contact Karanvir Sharma ( / ) for more details.