Process Engineer - Quality

The Quality Process Engineer leads the development and improvement of processes through analysis and strategic planning. The Quality Process Engineer works with cross functional teams in developing efficient and effective processes, workflows, equipment / components, and procedures thereby increasing process reliability, efficiency and lowering processing costs.

• Defines, characterizes, and leads the implementation and qualification of new processes, equipment, suppliers and components.
• Assures sound engineering and validation principals are applied to process and procedure design.
• Creates or assists in the creation of associated documentation such as procedures, validation documentation, control plans, audits, Non-Conformances, CAPAs.
• Coordinates quality focused processes such as CAPA, MRB/Non-Conformance and Internal Audit; pFMEA review.
• Manages projects to assure on-time/on budget implementation.
• Monitors and maintains process controls.
• Leads process improvements while mentoring others to improve processes.
• Generates and modifies manufacturing process documentation assuring that manufacturing processes and related documentation follow established policies and procedures.
• Works with R&D, Quality, and Manufacturing departments during the concept, prototyping, and release of new products into production.
• Other assignments as required.

• Requires a multidisciplined background with a focus on quality, manufacturing engineering and production operations.
• Demonstrated success in process improvements and project management.
• Excellent organizational skills and attention to detail.
• Must have good documentation practices.
• Ability to multitask.
• A proven understanding of part and quality workmanship.
• Communication skills - must have good listening skills in addition to excellent verbal and written communication abilities.
• Must be capable and willing to share knowledge and develop associates.
• Ability to analyze data and make recommendations.
• Strong interpersonal skills.
• Bilingual English/Spanish a plus.
• Ability to work with all levels of personnel from company president to production associates.

• Bachelor’s degree in Mechanical Engineering or equivalent.
• Minimum of 5 years’ experience in a fast-paced manufacturing environment.
• Experience/knowledge with process and equipment validation, IQ/OQ/PQ, etc.
  
  CAD experience/knowledge a plus.
• Must be an intermediate to advanced skilled user of Excel.

• While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to wet and/or humid conditions, ambient air, fumes, or airborne particles.
• The noise level in the work environment is usually moderate, but occasionally high requiring safety equipment to be utilized.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Candidate must be able to perform the physical responsibilities of the job utilizing arms, hands, and fingers to perform complex functions of manufacturing parts and performing other duties of the job, e.g., standing, sitting, walking throughout the facility and stairs, bending, squatting, and kneeling, etc.
• Ability to lift items weighing 10-15 lbs.

• Paid holidays
• Employee Assistance Program

• Medical, Dental, Vision, Basic Life/AD&D Insurance, Voluntary Term Life/AD&D Insurance
• Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Account, Commuter Transportation Management Account
• Vacation time
• Sick time

• 401…