The Staff Supplier Quality Engineer (SQE) will be responsible for supplier quality engineering activities focused on Reagents along with supporting Consumables and Instruments for New Product Introduction (NPI) and Production/Sustaining. SQE shall handle supplier quality engineering duties associated with suppliers including developing collaborative business partnerships and interfacing with suppliers, manufacturing operations, engineering, and supply chain to drive quality improvements and maintaining compliance. SQE shall also ensure suppliers deliver quality parts, materials, and services meeting requirements. SQE shall also provide direction and drive implementation for Supplier Quality systems' improvement. Candidate shall select and qualify suppliers according to company standards and monitor parts from delivery through the manufacturing cycle and communicates and resolves supplier-related problems as they occur. SQE shall develop and execute an auditing schedule to ensure that designated suppliers are audited for qualification and ongoing basis to ensure good manufacturing practices (GMP) and quality standards are met. Shall also evaluate suppliers' internal functions to assess their overall capability, performance and provides feedback in assessment of their operation.
Supplier Production/Sustaining and Qualification:
Understand and apply the manufacturing quality toolset including NCR, SCAR, Supplier Review Board, MRB, PFMEA, IQ, OQ, PQ, test method validations (e.g. Gage R&R), control plans, process verification/validation plans, validation protocol development, Cpk/PpK, SPC, hard gauging applications, computer-based inspection methods, operator work instructions, DOE, process data analysis, and DMAIC.
Lead supplier audits for Quality Systems and Capability, and supplier evaluations. Define and establish needed quality initiatives.
Develop and improve supplier quality system procedures through cross-functional teams and implement best practices.
Work with product support teams, engineering and others on supplier quality issues, supplier process changes, supplier quality agreements, and supplier initiatives.
Direct vendor interactions including travel to supplier sites. Travel time is approximately 10% percent.
Assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution. Develop control plans that identify inspection characteristics, gauging techniques, equivalence studies, and sampling requirements. Work with manufacturing sites to resolve conflicts and recommend revisions as required.
Review product verification and validation plans and approve reports.
Support the applicable site Quality System
Support Engineering and Supply Chain Projects
Participate in engineering projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.
Review drawings and specifications to evaluate quality requirements including correct application of geometric dimensioning and tolerancing (GD&T), proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Review and approve engineering change orders.
New Product Introduction (NPI)
Provide project(s) with direction on sound design control strategy for suppliers during product development ensuring compliance with QSR and QMS, supporting a product release that is safe and effective, sustainable in the field, and able to withstand an external audit
Technical Quality liaison between supplier and product development
Review supplier validation and qualification protocols and reports to ensure outputs will or have met input requirements, acceptance criteria was appropriately defined and has been met and any deviations have appropriate rationale and are documented correctly
Work with NPI Quality Engineering and Supply Chain to help scope and attend technical assessments and design reviews by providing quality system regulation and supplier selection guidance
Review test plans for appropriate size/scope to meet product intended use, claims, customer and marketing requirements, functional and regulatory requirements
Help scope a QSR compliant and effective risk management plan
Attend and guide product risk assessments, ensuring effective hazard identification, appropriate risk controls identification, and appropriate documentation of risk assessments
Bachelor's Degree in Biomedical, Chemistry, Biological Science or related discipline and a minimum of eight (8) years related experience
Certified Quality Auditor
Knowledge and Skills
Strong background and experience in a Supplier or Process Quality Engineering role in Reagent Manufacturing.
Strong background and experience in a Quality Engineering role for Instrumentation hardware validations/qualification.
Experience in the application of production and process controls including process validation, process control plans and statistical process control.
Experience in utilization and application of Statistical methods for computing and analyzing data, and driving measures and actions for improvement
Experience in initiating and driving Manufacturing Process and Quality System improvements working in a Team Environment. Must be able to interpret internal/external business challenges and recommend best practices to improve products, processes, and services
Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
Experience in leading quality system audits.
Superior communication skills, both oral and written.
Ability to work effectively in a team environment and build strong working relationships.
Ability to constructively challenge concerns and engage in transparent conversations.
Ability to identify, analyze and solve complex problems with minimal direction and make decisions with confidence. Must be able to take a broad perspective to identify innovative solutions
Foster an environment that values diversity and inclusion.
Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills).
High degree of initiative and self-motivation.
Strong analytical and problem-solving skills.
Proficient with Microsoft Office (Word, Excel, PowerPoint).
Experience in the medical device industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485
Experience in Bio-Process Engineering role with Reagent Product
Experience with Instrumentation and Injection Molding
Bachelor's Degree in Biomedical, Chemistry, Biological Science or related discipline and a minimum of 5 years related experience
A quality engineering certification from the American Society for Quality (ASQ), or other qualifying organizations. Examples include the CQE, CRE, CQA, etc.
Certified in Lean manufacturing and/or Six Sigma
Experience in product mechanical evaluation & dimensional testing and GD&T
Experience in Supplier Product Submissions such as PPAP