Quality Assurance Engineer (Contract Opportunity)

Overview : 6 month (potential to extend) contract opportunity and client is ready to hire!

Provide supplier quality engineering support to Manufacturing Operations by establishing and monitoring Key Process Indicators (KPI), leading problem solving to address supplier quality-related issues, improving component quality, and supporting customer complaint investigations related to supplied components. Utilize Corrective and Preventive Action system to pursue continuous improvement of the Quality System and products. Play an active role in cost reduction projects supporting Lean initiatives. Partner with Supply Chain, Manufacturing and Product Engineering teams by navigating changes, supporting validations, and leading component qualification and inspection plans as they relate to product quality.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Effectively partners with suppliers to ensure products conform to specifications and quality standards while driving continuous improvement with vendors.
• Implement FMEA/risk-based incoming inspection processes and lead quality at the source initiatives.
• Systematically monitor risk in supply chain through the vendor approval process, onsite assessments, and supplier metrics.
• Communicate quality issues to suppliers and the value stream through proactive relationships.
• Evaluate proposed changes at suppliers and support change management.
• Design and/or specify inspection and testing procedures/systems
• Lead the supplier corrective action process (SCAR) and investigate/analyze in-house and field failures (complaints), and improve product quality by determining root cause and recommending corrective actions.
• Propose, recommend, and oversee implementation of component and process improvements based on quality trends.
• Participate in investigation and analysis of customer complaints and field service trends.
• Review and approve disposition for Nonconforming Product and support Material Review Board (MRB).
• Author, review and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures related to supplied components.
• Lead efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance.
• Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.
• Be key participant in CAPA Committee and any Data Review Committees.
• Closely partner with Purchasing/Planning commodity teams and interface with personnel from all areas of the company to foster improved quality and efficiency.
• Communicate supplier quality metrics and project status to Focus Factory leadership.
• Utilize QA Inspectors and Technicians as resources and key partners in Quality.
  
  JOB SPECIFICATIONS:

• BS in Engineering (or equivalent) and a minimum of 2 years quality engineering work experience in the medical device industry, 4 plus years if experience is a non-life science industry.
• Experience/familiarity with regulated product quality system requirements, i.e. ISO 13485, FDA Quality System Regulations, ISO 14971, and other applicable standards.
• Relevant experience with supplier quality systems and processes including Supplier Corrective Actions (SCAR), Production Part Approval (PPAP), First Article Inspection (FAI), Supplier Quality Agreements, Supplier Audits, Supplier Transitions, and Product Change Notifications.
• Practical knowledge and experience in statistical analysis, problem-solving, process improvement techniques, Corrective and Preventive Action, Quality Plans, PFMEA, and manufacturing process validation.
• Must be able to read and understand component/product specifications. GD&T knowledge desirable.
• Familiarity with a variety of components and manufacturing processes including electro-mechanical components, valves, pumps, circuit boards, electrical harnesses, metal fabrication, and plastic molding desirable.
• Must have competent PC skills and be proficient with Microsoft Word and PowerPoint. Advanced level skills in Excel required. Experience using Minitab statistical software is desirable.
• Experience writing standard operating procedures and work instructions, implementing new processes, and training employees or suppliers accordingly.
• Must have practical knowledge and experience in statistical analysis, problem-solving/process improvement techniques, and Root Cause Investigation/CAPA.
• Familiar with the proper use of common inspection tools, test equipment, and visual standards.
• Must be able to read and understand component/product specifications.

Preferred Qualifications:

• 2 years' experience in a Supplier Quality function.

About Advantage Resourcing

Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.