Sr Product Quality Engineer (Direct Hire - Benefits!! - 100K+)

Schulte Staffing is actively seeking a SR Product Quality Engineer for a growing manufacturing company.This is a DIRECT HIRE opportunity with EXCEPTIONAL benefits!

The responsibilities include assisting in examination and approval of components and finished products, equipment, processes and related documentation. Utilizing different tools and techniques, the Quality Engineer will help ensure that only the highest quality products are delivered to our customers.

This is a full-time position, Monday through Friday, during normal business hours.
Pay Rate: $100,000K - $110,000K
Essential Functions

• Lead investigations of manufacturing nonconformities and assist manufacturing in implementing effective corrective actions
• Participates in audits conducted by regulatory agencies and/or customers and conducts internal QMS and manufacturing processes audits.
• Apply statistical process control (SPC) methods to evaluate current processes and process changes
• Collaborate and support company-wide CAPA and non-conformance implementation and continuous improvement projects
• Participates in supplier auditing, evaluation and selection process. Works with supplier to address supplier related nonconformities.
• Participates or lead risk management activities including FMEA and development of control plans
• Ensures compliance and operational effectiveness in all areas of the QMS including change control, training, complaint handling, CAPA, nonconforming process and auditing (internal and external).
• Works in collaboration with Product Development to ensure that the designs, procedures and outcomes of the project are meeting customer and QMS requirements.
• Collaborate with cross-functional teams to establish and maintain quality control processes and procedures
• Monitor and track key quality metrics, creating reports to identify trends and areas for improvement
• Adhere to safety, environmental, and quality-related policies and procedures in the facility.
• Performs other duties as required.

Requirements

• Bachelor's degree in an engineering discipline with effective communication and interpersonal skills for establishing relationships internally and externally
• Experience with statistical methods including MSA, process capability analyses, and design of experiments.
• Proficient with Microsoft Word, Excel & PowerPoint, Minitab (or other statistical software suites)
• Demonstrated proficiency leading teams and projects using a fact-based problem-solving methodology (DMAIC or 8D).
• Experience with developing, writing and implementing processes and procedures.
• Demonstrated ability to understand and communicate complex technical, statistical and compliance subject matter.
• Ability to manage and prioritize multiple activities with varying business, compliance and customer drivers
• Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations.
• Demonstrated proficiency in basic metrology and GD&T.
• Proficiency in applying quality problem-solving methods like FMEA, SPC, control plans, etc.
• Analytical thinking, attention to detail, problem-solving, and failure analysis aptitude
• Possess a strong quality mindset, ability to handle tight deadlines, and manage multiple priorities.

Required Education and Experience

• Minimum of 8 years of overall Engineering experience in an ISO (regulated environment, with at least 5 years in a direct Quality role is required
• Minimum of 8 years of overall Engineering experience in an ISO (FDA is a plus) regulated environment
• College degree or equivalent is required.

Must be able to complete a pre-employment physical and 11-panel drug screen that includes THC.
All interested candidates should apply directly to this ad or contact Chris or Julie at Schulte Staffing 978-594-0497
***This position is restricted to U.S. citizens due to U.S. government contract regulations that require the employment of only persons who are U.S. citizens. Must have the ability to obtain a DOD Security Clearance***