Job description

ViTalent, a leader in talent development and talent acquisition strategies focused in life sciences, is pleased to present the following opportunity with a key industry partner.

We seek 4 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

· Track and report key Quality metrics

· 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.

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

· Interacts regularly and effectively communicates with the key internal leaders and relevant stakeholders

· Participate in customer technical meetings in order to provide technical services supporting relevant quality topics

Skills & Experience

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

Technical Competences

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

Job Type: Full-time

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

Benefits:

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

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Fishers, IN: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001 (Preferred)
• CGMP (Required)
• Quality systems (Required)

Work Location: In person

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