The Senior/Staff Supplier Quality Engineer plays an integral role in supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company's quality system activities that comply with the FDA's Quality System Regulation and ISO 13485 and CLIA, CAP, and applicable state requirements.
• Own all aspects of global supplier relationships and technical processes that impact the Cost of Quality (COQ) to GRAIL's products.
• You'll be tasked with measuring, preventing, reacting, and enforcing key processes and procedures to manage suppliers reactively and proactively with minimal supervision.
• Ensure the performance of all required supplier maintenance activities meet current quality needs and to improve supplier performance and productivity.
• Strategically plan, develop, promote, and implement programs designed to improve supplier performance and productivity and reduce overall costs.
• Plans organize and report supplier performance to provide essential information to the management team.
• Participate in the supplier selection process and perform supplier audits to evaluate supplier capabilities, quality systems, processes, and services.
• Perform validations and qualifications of suppliers to qualify the manufacturing process and overall quality of part/component manufacturing.
• Assists incoming quality and participates in the MRB process to resolve internal and external quality audit findings related to purchased products.
• Own and relentlessly drive supplier root cause analysis and corrective actions to prevent the recurrence of quality issues.
• Provide statistical support by creating supplier-related metrics for tracking vendor performance and identifying opportunities for supply chain improvements.
• Ensure primary suppliers have adequate control plans, schedules, and resources to make continued improvements to the incoming quality of supplied products.
• Works with Engineering and Quality to ensure that incoming product specifications contain and clearly communicate the requirements needed to ensure supplied products are acceptable for manufacturing and assist in developing inspection methods and improving sampling plans for new materials and components.
• Identifies non-conformance trends; develops and administers technical investigations and corrective action programs to resolve recurring quality problems.
• Provide technical assistance to suppliers/other resources performing qualification/validation testing.
• Uses Quality Engineering tools (i.e. FMEA) to solve complex problems.
• Create and maintain a plan to help with the development of direct reports and their professional growth.
Auditing, Supplier Audits, Corrective Actions, Change Control, Supplier Performance Control, Raw Material Management, Gap Analysis, Quality Agreements
SCAR: supplier corrective action request
• Bachelor's Degree in Engineering or Science field.
• 5 to 8 years' experience in a QMS environment with 2 to 4 years working as a supplier quality engineer.
• 5+ years of supplier quality experience in the Life Sciences Industry, with prior experience in an FDA regulated environment.
• Have a strong background in applying statistical tools for process and product development and control (i.e. Gage R&R, Process Capability, Control Plans, SPC, Process Failure Mode Effects Analysis (PFMEA), and Design of Experiments (DOEs)).
• Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CRF 820, ISO 13485, IVDD, and other applicable quality and regulatory standards).
• Experience in all aspects of supplier quality, including supplier assessments/audits, maintaining a supplier evaluation program, supplier corrective actions, and supplier process changes.
• Effective verbal and written communication skills and the ability to share and receive information from all levels of the organization throughout various departments.
• Travel will be required up to 25% of the time, both domestically and internationally.
• Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.