QUALITY ASSURANCE ENGINEER 2

Amick Brown is seeking an experienced QUALITY ASSURANCE ENGINEER 2 for our direct client.

Location: Chapel Hill, NC

Duration: 6 months

Estimated pay range: $76 - 95 per hour per client contract and candidate skills, experience and work location.

Job Description

• 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%)

Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.

Regular full-time employees are eligible for the following Amick Brown provided benefits:

• Health
• Vision
• Dental
• 401k with company match
• Paid time off.
• Sick Leave
• Long -Term Disability
• Life Insurance
• Wellness & Discount Programs