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.
Staff Engineer Supply Quality
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Supply Quality Staff Engineer, are to:
- Leverage their breadth of engineering knowledge to lead technical projects in supplier quality systems and supplier related product development efforts;
- Independently plan and manage own work activities to given project objectives;
- Manage projects and supplier relationships to optimize performance at supplier locations, Supply Centers and other operational affiliates;
- Demonstrate advanced understanding of Medical Device operations, V&V, ISO standards and quality and regulatory requirements and fundamental knowledge of various manufacturing processes;
- Utilize statistical analyses to reduce risk and enable success of projects;
- Form and maintain trusted partnerships with suppliers, supply center leadership, Research and development (R&D), and internal stakeholder to lead project initiatives and drive accountability in manufacturing processes, externally and internally;
- Create, assign, and track project tasks with the supplier and then align with the Bayer project teams on supplier's progress to meet objectives and deliver in accordance with the timeline;
- Identify, select, and qualify suppliers in collaboration with a cross-function team to achieve to most qualified source for purchased components;
- Lead and monitor process validations (IQ, OQ, PQ) at supplier sites (as-needed);
- Be comfortable with Failure Analysis Methodologies to drive Supplier Corrective actions;
- Communicate technical matters in a manner that effectively conveys messages to diverse audiences;
- Become a qualified auditor and perform ISO 9001 or ISO 13485 QMS audits at suppliers.
This role is open to applicants that require domestic relocation.
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:
- Bachelor’s Degree in Engineering with at least seven years using relevant quality, supplier management or medical device manufacturing knowledge across a breadth of technical disciplines;
- At least three years of Technical leadership which can include but not limited to, leading process improvements, performing audits, and 8D corrective actions;
- Driven individual who seeks to identify and implement improvements in processes to improve the quality of our products for our patients;
- Collaborative and team-oriented contributor;
- Ability to influence others and effectively communicate messages to gain alignment across various stakeholders;
- General engineering knowledge crossing into other technical disciplines;
- Demonstrate skill in both analysis of complex problems and synthesis of solutions;
- Demonstrate excellent judgment in technical trade-offs and analyses;
- Working knowledge and proven skills of PC computer operating system, including Microsoft office applications (Outlook, Word, Excel, and PowerPoint).
- Master’s degree.
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. 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.
IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer active employees are required to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status before participating in approved activities for fully vaccinated employees. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, if candidates are invited on site as visitors for in person interviews, they must provide proof of being vaccinated and comply with all safety protocols.
Location: Pittsburgh Heilman
Reference Code: 520601
Functional Area: Engineering & Technology
Entry Level : Professional