Quality Engineer

First Quality • Lewistown, PA

6d • Onsite

About The Position

This position will be responsible for quality-assurance support on assigned program(s) and/or areas to ensure that the product is designed, procured, and built in accordance with customer and industry quality requirements. To provide leadership for new systems development, implementation, procedures, and any related quality activity.

Requirements

• ASQ Certification or equivalent training (CQA or CQT required; CQE preferred).
• Familiarity with formal Quality System (ISO 13485, 21 CFR Part 820, ISO 9001, GMP/QSR, etc.)
• Strong communication skills.
• Demonstrated team leadership ability.
• Bachelor’s degree in Engineering discipline and two or more years in quality or manufacturing engineering, (or) Bachelor’s degree in a scientific/technical field with five or more years of experience in quality or manufacturing engineering disciplines.

Nice To Haves

• Experience in statistics, procedure implementation, and quality auditing preferred.

Responsibilities

• Supervises the activities, performance review and disciplinary actions of assigned staff.
• Understands and performs quality testing according to approved procedures.
• Regularly reviews quality data to identify opportunity for corrective & preventive action.
• Ensures that statistical methods are applied to testing, validation, sampling and inspection activities and quality investigations.
• Participates in and leads teams in quality system improvement, new product development, cost savings, and other quality initiatives.
• Coordinates the resolution of customer complaints/non-conformance issues.
• Acts as primary QA contact in supplier assessment and raw material qualification activities.
• Leads/Participates in internal and customer audits of the quality system.
• Oversees proper use and control of QA Department quality records.
• Devises or revises procedures related to the Quality Management System.
• Reports significant issues or developments identified during quality activities and provides recommended process improvements to management.
• Prepares and presents quality system information to team members.
• Performs laboratory tours and provides Quality System explanations to visitors.
• Observes all safety rules and uses the proper safety equipment at all times.
• Follows necessary GMP, and regulatory requirements.
• Performs other duties as necessary when directed to do so.

Benefits

• Competitive base salary and bonus opportunities
• Paid time off (three-week minimum)
• Medical, dental and vision starting day one
• 401(k) with employer match
• Paid parental leave
• Child and family care assistance (dependent care FSA with employer match up to $2500)
• Bundle of joy benefit (year's worth of free diapers to all team members with a new baby)
• Tuition assistance
• Wellness program with savings of up to $4,000 per year on insurance premiums

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level