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Quality Assurance Engineer

2 months ago

Palm Harbor, Florida, United States T S E INDUSTRIES INC. Full time
Job Summary

We are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our team at TSE Industries Inc. as an Associate Quality Engineer. This role will be responsible for assisting the Senior Quality Engineer and/or Quality Manager in all aspects of WHK Quality, including customer complaints, training, Quality Metrics, Audits, CAPAs, Quality Documentation, and Quality Control.

Key Responsibilities
  • Assist the team in problem-solving to identify root causes and corrective actions/preventive actions.
  • Assist in creating and revising assembly procedures.
  • Provide support to Engineering Projects via Engineering Change Orders (ECO). This includes but is not limited to the creation, review, and approval of procedures, specifications, inspection plans, and quality records.
  • Assist the Senior Quality Engineer and/or Quality Manager in maintaining Quality Metrics and KPIs. Perform trend analysis and identify action plans.
  • Assist the Senior Quality Engineer and/or Quality Manager to prepare for customer audits and third-party audits.
  • Participate in customer/external audits and assist the Senior Quality Engineer and/or Quality Manager with any preparation or reporting as directed.
  • Participate in the initiation and resolution of CAPAs.
  • Update, evaluate returned product under RMA process; interface with customer service and/or customer as necessary.
  • Report improvements to management and appropriate cross-functional teams.
  • Lead and participate in other projects as needed.
Quality Control
  • Perform Final Product Release, Incoming Inspection and Release, Production Inspection, Non-Conformances, DMRs, Calibration (via GagePack), and Label Approvals.
  • Perform and oversee the review, storage, and disposition of Quality records in accordance with cGMP and ISO13485:2016.
  • Communicate with vendors when necessary to request vendor certifications and other documents, e.g., First Articles as required.
  • Oversee preventive maintenance for tools and fixtures to ensure that PM tasks are performed accurately and in a timely manner.
  • Perform and oversee the review, storage, and disposition of Quality records in accordance with cGMP and ISO13485:2016.
  • Work with Quality, Engineering, and Production QC inspector(s) and/or production to resolve non-conformances in a timely manner so as to meet specified shipment dates.
  • Assist in orientation of new technicians and inspection processes, as necessary.
  • Prepare Certifications for shipments.
  • Assist the Senior Quality Engineer and/or Quality Manager in processing rejects and returns by utilizing Epicor ERP.
  • Assist in identifying and implementing areas for quality control improvement.
  • Communicate quality or compliance concerns with urgency.
Requirements
  • Minimum of a high school degree or GED is required. A BA/BS in a technical or engineering field is preferred.
  • A minimum of 2 years of experience working in a professional office and manufacturing environment is required.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions is required.
  • Energetic, with strong interpersonal, organizational, and communication skills are required.
  • Excellent verbal and written communication skills are required.
  • Demonstrated ability to accomplish work goals is required.
  • Quality Engineering experience in the Medical Device or similar field is preferred.
  • Experience with statistical analysis, root cause problem-solving, and validations is preferred.
  • Cleanroom experience is a plus.
  • GMP experience in an FDA/Health Canada/ISO regulated industry or similar is a plus.
Language Skills

Must possess the ability to express thoughts clearly, both verbally and in written context. Must have strong knowledge in working with the MS Office Suite.

Mathematical Skills

An understanding of all basic mathematical skills.

Reasoning Ability

Should be familiar with the different processes required to process materials through a manufacturing environment. This knowledge would help the individual to be able to install necessary inspection points throughout the manufacturing operations.

Physical Demands

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, and use hands to finger, handle, or feel. The employee is occasionally required to sit. The employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and ability to adjust focus. Must have the ability to travel for business purposes.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and environmental restrictions. The noise level in the work environment is usually moderate.