Quality Engineer

Location

South Bend, IN | United States

Job description

Quality Engineer

Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking for a Quality Engineer.

Job Description:

This Quality Engineer oversees the manufacturing and engineering processes by ensuring the proper use of tools, materials, and procedures to monitor, test and report on the quality of the products.  The Quality Engineer is responsible for the generation of a strategic plan to improve the business processes by ensuring compliance of the products and increase production output. The Quality Engineer must be self-directed and must show initiative in identifying and resolving opportunities for improvement, promoting Quality initiatives, and driving continual improvement in the Quality System. The Quality Engineer will pay close attention to detail, must possess analytical/critical thinking/problem-solving skills, possess excellent communication, ethics, math, and interpersonal skills.

Responsibilities:

• Supports efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality.  Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
• Supports/leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Identifies areas of systemic weakness and leads initiatives to implement corrective action. Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation.
• Implement and monitor all procedures and processes as they relate to Quarantine, Hold, Expired, Damages, Return Goods and Recalled product.
• Evaluate proposed changes for design control requirements. Guides engineering/ manufacturing personnel of appropriate qualification, validation criteria.
• Provides routine analysis of performance indicators and identifies trends. Presents this information to management, supervisors and manufacturing operators. Supports/leads initiatives to improve performance.
• Supports/leads teams to update risk management files for process changes.  Focus team on implementing capable processes, process controls, and error-proofing measures.
• Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements and continuous improvement.
• Monitoring the in-process quality check on the line.
• Reviews new Batch records and SOPs.
• Other duties as assigned.

Education and/or Experience:

• BA or BS Degree in Engineering, Quality Control or related field.
• 5 years relevant experience in Quality Engineering /manufacturing/ production processes
• Familiarity with industrial automation (e.g., distributed control and PLC-based systems)
• Working knowledge of safety, quality systems, and GMPs is required.

Benefits

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training.  Work where you are HAPPY!Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.

Thank you for your interest and consideration of a career with Tri-Pac, Inc.

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer

To Staffing & Recruitment Agencies : Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

Job tags

Salary