Quality Engineer - BioPharma
Trelleborg is a world leader in engineered polymer solutions that protect critical applications in demanding environments. Its innovative solutions accelerate performance for customers in a sustainable way. And we are where we are because our talents brought us here. In 2023, the Trelleborg Group had annual sales of approximately SEK 34 billion in around 40 countries. The Group comprises three business areas: Trelleborg Industrial Solutions, Trelleborg Medical Solutions and Trelleborg Sealing Solutions. The Trelleborg share has been listed on the Stock Exchange since 1964 and is listed on Nasdaq Stockholm, Large Cap. www.trelleborg.com
We are looking for a Quality Engineer to work in the new BioPharma division located in Trelleborg, Hal Far.
The Quality Engineer will be responsible for the development and administration of a Quality System compliant to FDA and ISO requirements, including the utilization of optimal, cost-effective lean manufacturing processes and methods for new and existing projects including inspection, test and label control operations. Working with internal and external customers supports, quality and continuous improvement using appropriate tools, project leadership.
Duties, responsibilities, and authorities:
- Supports internal audit program as necessary.
- Supports customer complaint (CC) and RMA system per procedures. Performs investigations, supports determination of the disposition of returned goods, determines re-inspection requirements, determines corrective and preventive actions (CAPA), issues complaint reports, supports completion of customer CAPAs, and approves to close. Looks for trends to determine actions to decrease number of CCs.
- Maintains Non-Conforming (NC) system per procedures. Performs investigations, participates in MRB (Material Review Board) activities, supports determination of the disposition, determines re-inspection requirement, supports determination of corrections/corrective actions, and approves to close. Looks for trends to decrease number of NCs and provide feedback to management.
- Maintains corrective and preventive action (CAPA) system per procedures. Initiates and performs root cause analysis. Uses statistical and capability analysis to solve problems. Implements and verifies CAPAs.
- Performs trend analysis of CAPA, NCM, Complaint/Customer Feedback, Risk Management activities, Audits, etc. and presents periodic reports for management review. Assesses Design and any associated activities for manufacturability.
- Adheres to the company’s Quality System (QS), writes, and approves QS documents.
- Authors and executes Quality Plans for Quality Management Systems and Organizational Objectives projects.
- Support Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of product quality.
- Communicates with customers on complaints, process changes, clarification of specifications, completing customer documents, and other projects as needed.
- Conducts studies including Gauge R&R’s to develop inspection methods and test equipment. Creates measurement system programs, when necessary.
- Establishes inspections and sampling procedures to ensure the control of quality at the most economical costs.
- Creates, reviews, and approves Equipment Qualifications, Process, Cleaning, and Software Validation, pFMEA and other documentation as necessary.
- Participates in customer and ISO audits.
- Works closely with internal resources to establish processes and resolve issues.
- Supports implementation best practices through the application of effective quality engineering principals and procedures across functions.
- Ensures proper controls are being systematically applied to both new and legacy products.
- Supports internal and external audits.
Education and Experience:
Required:
- 4 year degree in quality, engineering or any related field
Desired:
- 2+ years in a manufacturing environment in a technical support role
- ASQ Certified Quality Engineer
- Formal Six Sigma Yellow/ Green belt training
Competencies:
- Ability to read, write, speak, and understand the English language.
- Ability to communicate clearly by conveying and receiving ideas, information, and direction effectively.
- Ability to demonstrate adequate job knowledge to deliver a world class performance.
- Ability to challenge oneself to consistently meet all goals and deadlines.
- Willingness to strive for excellence by producing work that is free of errors and mistakes.
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork, and addressing conflict appropriately.
- Commitment to making improvements company wide.
- Demonstrated competence using Microsoft Office, Project, Access and JMP
- Comprehensive understanding of applicable Work Instructions, SOP’S, and ISO standards
- Working knowledge of statistical methods associated with six sigma and quality control.
- Able to perform math functions.
- Effective project leader
- Experience with lean manufacturing principles and their implementation.
Ansökan
Välj dina intresseområden
Jobbar du redan på Trelleborg?
Hjälp till i rekryteringen och hitta din framtida kollega. Ange din epost nedan för att få instruktioner om hur du blir en influencer.