Quality Engineer Jobs

ViTalent (FKA CREST), a leader in talent development and talent acquisition strategies focused in life sciences, clinical research and healthcare is pleased to present the following opportunity with a key industry partner.

We seek 2 Quality Engineers with experience in regulatory environments (FDA, GMP, Life Sciences) to support all aspects of the Quality Management System, Product Realization, and Manufacturing Process Controls.

Our client, the Stevanato Group, is a 70 year old international leader specializing in world-class systems, processes and services for the Pharmaceutical and Healthcare industries. With global operations including 14 production and commercial sites, the company is poised for continued growth in the sustainable life sciences sector. The organization has committed to an even stronger US presence locating in Fishers, Indiana. A new, world-class facility is underway, so this is an exciting time to join an innovative and forward thinking organization.

The candidate selected for the role will enjoy a very competitive pay package and industry leading benefits.

The quality engineers apply best practices from within the field of quality control to ensure that the materials, components, processes, and manufacturing techniques used produce high quality and reliable products. They will work with cross functional partners, define and generate quality control plans, production process controls, and procedures. They lead and support validation activities including statistical analysis. They will execute process capabilities analysis and investigation of deviations and customer complaints, ensuring quality technical issue resolution. They will engage with customers to oversee investigations and address quality issues and define acceptance criteria/attributes.

ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES

QUALITY PROCESS MONITORING

• Collaborate with cross functional teams to investigate and trend deviations/OOS and customer complaints to identify CAPAs to drive improvements to product quality
• Plan and perform regular audits of quality system and drive system improvements through the CAPA system.
• Track and report key Quality metrics

QUALITY DOCUMENTATION

• Verify customer product specs align with site capabilities to support customer quality expectations
• Maintain repository for the relevant technical and quality documents
• Participate in inspections/audits by providing applicable information to fulfill requests of inspectors/customers

VALIDATION MANAGEMENT

• Participates in carrying out new projects ensuring technical assistance and validation
• Collaborate with Operations and Engineering to ensure execution of the qualification and validation activities meet timing requirements
• Train quality staff in standard metrology, GD&T, SPC and new inspection techniques

RELATIONSHIP MANAGEMENT

• Participate in customer technical meetings in order to provide technical services supporting relevant quality topics
• Interacts regularly and effectively communicates with the key internal leaders and relevant stakeholders

Skills & Experience

• Bachelors of Science in Technical Field (i.e. Engineering, Material Science, Data Analytics, Statistics, etc.) or equivalent work experience.
• Strong Problem Solving Skills
• 4-7 years experience in Quality Assurance/Quality Engineering/Process Engineering in manufacturing
• Strong technical writing skills
• Strong Communication skills to varying audieces including ability to train technicians on complex technical topics and program specific quality standards
• Strong Project Management Skills
• Risk Based Thinking Approach

Technical Competences

• Working knowledge of statistical methods used in manufacturing.
• Project Management and Risk Management: methodologies, techniques, tools and applications
• Knowledge of technologies and control strategies for relevant manufacturing processes in a medical device and/or pharma industry.
• Proficient in Geometric Dimensioning and Tolerancing (ANSI Y-14.5
• Proficient in metrology and calibration techniques.
• Knowledge of applicable regulatory standards such as ISO 9001, ISO 13485 and applicable FDA cGMPs
• Knowledge of device manufacturing Quality Management System processes and features

Job Type: Full-time

Salary: $90,000.00 - $105,000.00 per year

Benefits:

• Parental leave
• Health insurance
• Employee assistance program
• Vision insurance
• Life insurance
• 401(k) matching
• Paid time off
• Flexible spending account
• Flexible schedule
• Employee discount
• Tuition reimbursement
• Dental insurance
• Health savings account
• 401(k)

Schedule:

• Day shift
• Weekend availability
• Monday to Friday

Work Location: In person

This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.

Responsibilities

• Design and implement methods for process control, process improvement, testing and inspection
• Develop, execute, and analyze quality reporting measures
• Participate in internal and external quality audits
• Perform problem identification, resolution, loss reporting and continuous improvement

Qualifications

• 4+ years' of experience in a quality engineer role; plus if direct GMP, life science industry experience
• Strong knowledge of quality tools used in the industry
• Analytical and quantitative approach to problem solving
• Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering