Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Plant Quality Engineer - Saxonburg

Your tasks and responsibilities

 

The primary responsibilities of this role, Plant Quality Engineer - Saxonburg, are to: 

 

  • Lead and support quality engineering activities which support manufacturing at the Saxonburg Plant;
  • Provide focused quality engineering support to develop, support and maintain quality engineering methodologies that meets Customer, Regulatory and Bayer requirements;
  • Lead the Material Review Board cross-functional team to investigate and address all manufacturing non-conformances;
  • Lead and support investigations by conducting problem solving and root cause analysis to address failures identified by customer complaints, internal non-conformances and manufacturing yields;
  • Lead and support documentation review activities that facilitate in the timeliness of product release;
  • Lead and support Corrective and Preventative Actions (CAPAs) to ensure effective identification and elimination of root causes and then subsequent closure of all actions as per the plan;
  • Lead and support all change management, exception management and continuous improvement activities across the manufacturing plants;
  • Lead / Support manufacturing validation activities (IQ, OQ, PQ, Test Method Validations);
  • Identify, create, maintain data and publish quality trends;
  • Identify and implement opportunities to improve quality system and manufacturing processes;
  • Support cost and quality improvement projects across manufacturing plants;
  • Understand and apply knowledge of product line and clinical applications to work activities, and to support new products or processes;
  • Understand relevant processes required to accomplish objectives.

     

Who you are

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Bachelor’s Degree in Engineering;
  • Two years of knowledge and application of engineering and scientific concepts in selected technical discipline;
  • Basic knowledge of other technical disciplines;
  • Ability to apply basic tools, methodologies and technologies, including statistics;
  • Ability to define requirements for simple designs and material selection;
  • Working knowledge and proven skills of PC computer system including Microsoft Office Applications (Outlook, Word, Excel, and PowerPoint);
  • Proven ability to work collaboratively in a manufacturing environment;
  • Strong communication and interpersonal skills with ability to work well in high pressure environment;
  • Proven ability to demonstrate analytical capabilities including designing and executing DOE’s, statistical analysis, analytical design tools etc.;
  • Proven knowledge in application of quality engineering and risk management tools such as statistics, Six Sigma, FMEA and problem solving methodologies;
  • Proven ability to demonstrate technical writing skills;
  • Knowledge of FDA QSR and ISO Quality Standards;
  • Proven ability to demonstrate high levels of Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion;
  • Proven ability to demonstrate at minimum, Bayer’s Team Contributor competencies: Action Oriented, Perseverance, Dealing with Ambiguity, Learning on the fly and Problem Solving.

 

Preferred Qualifications:

 

  • Direct experience within the medical device industry (FDA Regulated).

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

 

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

 

Country: United States
Location: PA-Saxonburg