Quality Engineer

Location: Germany

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Biotechnology and Medical Devices organization, based in Baden-Württemberg Germany.

is a global medical technology company that is focused on improving drug delivery, enhancing the diagnosis of infectious diseases and cancers, and advancing drug discovery. My client develops, manufactures and sells medical supplies, devices, laboratory instruments, antibodies, reagents and diagnostic products.

ROLE DESCRIPTION

The Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy's for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant.

The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. May support both internal and external audits by assuming the Lead Auditor role.

RESPONSIBILITIES

• Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies;
• Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments;
• Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans and design control;
• Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products;
• Responsible for initiating and coordinating SAP master data and documentation for product changes and new products;
• Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes;
• Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures;
• Serves as Quality expert for assigned Media product line;
• Supports internal and external audits, and assists in administering the audit program;
• Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals, and provides plant quality metrics as required to generate quality system improvements;
• Facilitates investigation of customer complaints. Implement revision to IT's based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints;
• Defines Change Control requirements for the plant related to manufacturing, facility and material changes. May provide full support to raw material changes assuring that all Quality Systems and requirements are met.

REQUIREMENTS

• Bachelor's or Master degree with 2 years experience (in a regulated environment) - Typical degree in Microbiology, Biological Sciences, Chemistry and/or Regulatory Affairs or other related field;
• German and English language skills;
• Six sigma, additionally root cause analysis and project management techniques are routinely employed;
• Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000, ISO 17025 (QC Labs) and ISO 13485:2003;
• Moderate knowledge of QC testing Laboratories and skill to drive root cause analysis of failed tests, test method improvements, and OOS resolution.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Onno Goedhart.