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Chapel Hill, NC 27514

Posted: 04/02/2024 Employment Type: Contract Industry: VMS Job Number: 28622

Job Description


Position Description: Protingent Staffing has an exciting contract opportunity for QUALITY ASSURANCE ENGINEER 2 with our client that is located in Chapel Hill, NC.

Job Responsibilities: 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.

• 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.

Job Qualifications:

• 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%).

Job Details:

• Contract: 6 months
• Pay Rate: $80-88 / hr
• Location: Chapel Hill, NC

Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.

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About Chapel Hill, NC

Discover exciting job opportunities in and around Chapel Hill, North Carolina! Nestled in the vibrant Research Triangle area, Chapel Hill offers a perfect blend of academic excellence, cultural richness, and Southern charm. Home to the University of North Carolina at Chapel Hill, this town boasts a creative atmosphere that extends to its numerous art galleries, like the FRANK Gallery, and theaters, such as the PlayMakers Repertory Company. With a thriving food scene that includes delicious Carolina barbecue and a lively sports culture, including games at the Dean Smith Center, there is something for everyone. Explore career growth in this dynamic region filled with picturesque parks, like Merritt's Pasture, and endless opportunities for personal and professional development. Discover your next career move in Chapel Hill today!