We are looking for a Quality Specialist (Job on site)to join our team in our plant in Brazil (Sete Lagoas/MG – job onsite) .
The chosen candidate will be supports all aspects of the Quality Management System, Product Realization, and Manufacturing Process Controls applying 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.
Working with cross functional partners, defines and generates quality control plans, production process controls, and procedures.
They lead and support validation activities including statistical analysis.
They execute process capabilities analysis and investigation of deviations and customer complaints, ensuring quality technical issue resolution.
Engages with customers to investigation and address quality issues and define acceptance criteria/attributes.
- Track and report key Quality metrics.
- Author, review, or approve technical reports evaluating trends and process/product performance data, identifying and clustering issues based on type, complexity and time to answer, targets, etc.
- Collaborate with cross functional team to investigate and trend deviations/OOS and customer complaints to identify CAPA to drive improvements to product quality.
This may include authoring, reviewing, or approving investigation reports as well as conducting/facilitating root cause investigations and owning/executing resulting CAPA activities.
- Locally deploy global quality and technical specifications for products and services in cooperation with internal stakeholders.
- Verify customer product specifications aligns with site capabilities to support customer quality expectations and implement efficient tools in handling SG and customer specifications compliant to applicable regulations.
- Participates in carrying out new projects ensuring technical assistance and validation.
- Supports the definition of the required qualification and validation activities, aimed at ensuring the compliance of the quality management system with applicable standards and requirements.
- Provides timely and accurate validation documents, including creation/review/approval of internal protocols and reports as well as consultation/review/approval of thirds party protocols and reports.
- Support the development and manufacturing of medical devices in conformance with applicable local regulations and ISO 13485 requirements.
- Ensure policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
- Train quality staff in standard metrology, GD&T, SPC and new inspection techniques.
- Executes the assigned projects related to product and process quality improvement, including development and implementation of any new or required inspection methods.
- Participate in inspections/audits by providing applicable information to fulfill requests of inspectors/customers with potential interactions to explain relevant data, documentation, and rationale.
- Interacts regularly and effectively communicates with the key internal leaders and team as well as relevant stakeholders aimed at building level of awareness on quality vision supporting them in facing quality issues Qualifications - +3 years of experiences proven experience in Quality Assurance/Quality Engineering/Process Engineering in manufacturing.
- Proficiency in English is required.
- Bachelors of Science in Technical Field (i.e.
Engineering, Material Science, Data Analytics, Statistics, etc.)
or equivalent work experience - Knowledge of applicable regulatory standards such as ISO 9001, ISO 13485 and GMPs - Knowledge of device manufacturing Quality Management System processes and features - Knowledge of technologies and control strategies for relevant manufacturing processes in a medical device and/or pharma industry.
- 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) - Skills: Problem Solving, Project Management and Strong Technical Writing - Risk Based Thinking Approach.
About Us We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results.
We are also growing and looking to hire talented and passionate individuals to join our team!