Associate Quality Engineer

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Associate Quality Engineer 

Associate Quality Engineer – Saxonburg, PA

Purpose:

This is an entry level position that has responsibility for supporting the Saxonburg manufacturing operation related to product and quality processes and may have responsibility for supporting manufacturing projects. Specifically, this position will support all quality engineering activities related to day-to-day manufacturing across multiple production processes in a regulated medical device manufacturing facility. This position shall provide support championing departmental and/or cross-functional engineering initiatives related to the implementation of medium complexity projects to meet BHC goals and priorities.

YOUR TASKS AND RESPONSIBILITIES

• The primary responsibilities of this role are to:
• Support quality engineering activities which support manufacturing at the Saxonburg Plant;
• Provide focused quality engineering support to maintain quality engineering methodologies that meets Customer, Regulatory and Bayer requirements;
• Support Material Review Board cross-functional team to investigate and address non-conformances;
• Lead/Support investigation by conducting problem solving and root cause analysis to address failures identified by customer complaints, internal non-conformance’s and manufacturing yields;
• Support CAPAs and QIA’s investigations to ensure effective closure of actions as per the plan;
• Identify, create, maintain data and publish quality trends;
• Support cost and quality improvement projects across manufacturing plants;
• Understands relevant processes required to accomplish objectives;
• Support internal audits of the Quality Management System in accordance with established requirements;
• Support external audits by regulatory agencies including FDA and Notified Body ISO-13485/MDSAP certification and surveillance audits;
• Monitor, assess and implement external standards and divisional policies to ensure alignment within the local quality system;
• Ensure the review and update of quality system documents are performed in order to assure compliance with Corporate and regulatory requirements.

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;
• Ability to work collaboratively;
• Strong communication and interpersonal skills with ability to work well in high pressure environment;
• Basic 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;
• Proven ability to demonstrate high levels of Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion.

PREFERRED QUALIFICATIONS

• Direct experience within the medical device industry (FDA Regulated);
• 0-2+ years of experience;
• Ability to demonstrate analytical capabilities (including designing and executing DOE’s, statistical analysis, analytical design tools etc.);
• Knowledge of FDA QSR and ISO Quality Standards.