Quality Systems Engineer - Injection Molding

EPTAM Precision; Lancaster (MA); On-site; USD 85,000 - 95,000; Full time

Job summary

EPTAM Precision Molding in Lancaster, MA is seeking a Quality Systems Engineer to lead and maintain the Quality Management System (QMS) within FDA and ISO 13485 environments. You will drive audits, CAPA, training, and data-driven improvement.

The role requires a Bachelor’s degree in engineering or STEM and at least 3 years of progressive manufacturing/quality experience. Strong analytical skills and collaboration with the Quality Manager are essential.

Qualifications

• Bachelor's degree in engineering or STEM preferred, but not required.
• 3 years of progressive experience in manufacturing and/or quality in FDA and ISO 13485 environments.

Responsibilities

• Perform root cause analysis and resolve problems.
• Manage CAPA and Customer Complaint Systems.
• Perform data analysis and trend reporting for management reviews.
• Oversee implementation and maintenance of the Quality Management System (QMS) and related accreditations.
• Organize internal plant audits and corrective action reporting.
• Assist with external Quality System audits and train internal auditors.

Skills

Root cause analysis

CAPA management

Quality management systems (QMS)

Auditing

Data analysis

Process improvement

Training and documentation

Education

Bachelor's degree in engineering or STEM

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Systems Engineer - Injection Molding

Full Time Professional Lancaster, MA, US

23 days ago Requisition ID: 1548

Salary Range: $85,000.00 To $95,000.00 Annually

EPTAM Precision Molding is looking for a Quality Systems Engineer to join our team in Lancaster, MA

EPTAM Precision Molding is a trusted injection molding solutions partner. We are dedicated to supporting the complete product lifecycle in consumer product. healthcare, and defense industries. We're committed to helping our customers bring their products to market and streamline their supply chain.

EPTAM Solutions , Our parent company with locations nationwide, is at the Heart of Manufacturing.

We recognize our parts touch lives, and our teams assume this responsibility with vigor. Our minds never sleep.

Join our incredible team at any one of our locations and reap the benefits of an employee-focused company. We excel at what we do for our customers, our employees, and the world.

Benefits Include:

• Professional Development/On the Job Training
• Health and Wellness Benefits
• Clean, Friendly, Safe work Environment
• Recognition and Rewards Program
• Tuition Re-imbursement
• Competitive Pay/Merit Increases
• 401k w/ Company Match
• Employee Assistance Program (EAP)

POSITION SUMMARY: The Quality Systems Engineer is primarily responsible for the following:

• Oversee effective implementation of the Quality Management System (QMS).
• Lead and undertake audits across all areas of the business.
• Provide training and champion the Quality Management System.
• Manage CAPA and Complaints systems and reporting performance.

ESSENTIAL FUNCTIONS:Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Perform root cause analysis and resolve problems.
• Manage the CAPA and Customer Complaint Systems.
• Perform data analysis and trending and report such trends in management reviews.
• Oversee effective implementation of the Quality Management System, including any business accreditations.
• Maintain the Quality Management System and ensure contents are appropriate for business, in collaboration with the Quality Manager.
• Organize and manage the plant internal audit system and the corrective action reporting system.
• Conduct Quality Systems audits and assist in training/guidance to internal auditors.
• Assist/support Quality Manager during external Quality System audits.
• Provide training on Quality issues and awareness.
• Coordinate the review of Quality procedures associated with plant continuous improvement initiatives.
• Compile quality data and report on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system.
• Employees must be able to relate to other people beyond receiving instructions. Can get along with co-workers or peers and respond appropriately to feedback from a supervisor in a professional manner.

OTHER RESPONSIBILITIES:

• Promote the use of customer preferred techniques for continuous improvement such as Six-Sigma, Poka-Yoke (Error Proofing), and Measurement System Analysis.
• Keep up with current and developing manufacturing and engineering trends that concern product quality.
• Support and lead process improvement activities.
• Understand the sensitivity of the data handled by systems under your control and take appropriate measures to protect it.

EDUCATION AND EXPERIENCE:

• EDUCATION: Bachelor's degree in an engineering field, or relevant technical field (STEM) preferred, but not required.
• EXPERIENCE: 3 year(s) of progressive experience in manufacturing and/or quality in an FDA, and ISO 13485 operating environment, demonstrating acumen, and understanding of QMS and Operations; equivalent combinations or education and experience accepted OR demonstrated ability to execute the Essential Functions for this position.
• LICENSES, CERTIFICATIONS AND/ REGISTRATIONS: None