Supplier Quality Engineer III

Job Purpose and Core Tasks

Provide technical support for supply chain management. Works closely with Purchasing and KARL STORZ suppliers to develop and implement product requirements and associated process controls. Implements and uses statistical analysis techniques to monitor supplier performance, spearheading any required actions in a continual improvement environment. Assists in the activities to move to and sustain Lean Manufacturing.

• Technical lead in the identification, development, and qualification of suppliers.
• Technical lead in the maintenance and improvement activities associated with supplier certification and supply chain management.

#LI-KM1

• Works closely with critical suppliers to review and implement statistical analysis techniques to ensure supplier process stability and capability and to monitor the performance of the supplier.
• Works closely with procurement and manufacturing to implement lean techniques in the production, receipt, and consumption of supplied products within KARL STORZ operations.
• Technical lead in identifying, developing, and approving results of any required supplier validation and re-validation protocols on new or changed supplier processes/products.
• Performs system, product, and process audits of suppliers to assist in developing suppliers and assuring continual improvement.
• Assists in the identification of critical dimensions and features of supplied products.
• Analyzes trends in product/process performance from new product development through service, coordinating any required root cause analysis and corrective action associated with suppliers.
• Assists in the review and disposition of non-conforming material received from suppliers.
• Support failure review activities.
• Attend MRB meetings as required.
• Regular attendance is an essential job function.
• Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KARL STORZ products and services.
• Performs system, process, and product assessments within KARL STORZ, spearheading any required follow-on actions.
• Assists in sustaining manufacturing and service processes.
• Performs other related duties as assigned by supervisor.

Minimum Knowledge, Education and Skill Requirements

Required

Minimum years of relevant work experience:

• Bachelor's Degree in an Engineering, Math, or related discipline with 4-8 years of experience in manufacturing or Masters in an Engineering, Math, or related discipline with 3-6 years of experience in manufacturing.
• Maintaining an ASQ certification as a Quality Engineer, Six Sigma Green Belt, or Six Sigma Black Belt will be considered in place of a Bachelor's degree.

Minimum education, certifications and/or credentials:

• Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001).
• Knowledgeable in GD&T and can explain clearly to Suppliers who don't understand.
• Working knowledge of Lean Six Sigma principles and Supply Chain Management.
• Working knowledge of statistical analysis techniques such as, but not limited to: SPC, DOE, pFMEA, and Measurement System Analysis.

Minimum hard skill requirements (including computer and application proficiency):

• Proficient in utilizing common "off the shelf" mechanical measuring and electronic test equipment.
• Able to read and comprehend engineering drawings and specification sheets.
• Demonstrated ability to successfully develop processes, define process controls, and validate process and product performance.
• Demonstrated ability to successfully manage multiple assignments and projects.
• Demonstrated ability to successfully lead teams in a consensus building effort towards a defined goal.

Minimum soft skill requirements:

• Strong written, verbal, analytical, and interpersonal skills.
• Good interpersonal skills to communicate clearly with manufacturing, purchasing, engineering, and supplier personnel.
• Must possess strong organizational skills.

Preferred

Preferred years of relevant work experience:

• Bachelor's Degree in an Engineering, Math, or related discipline with 5-8 years of experience in manufacturing or Masters in an Engineering, Math, or related discipline with 4-6 years of experience in manufacturing.

Preferred education, certifications and/or credentials:

• Experience in performing time studies and line balancing desired.
• ASQ certification desired.

Preferred hard skill requirements:

• Well-versed with GD&T and can explain clearly to Suppliers who don't understand.
• Well-versed with statistical analysis techniques such as, but not limited to: SPC, DOE, pFMEA, and Measurement System Analysis.
• Agile/SCRUM experience.
• Experience with Mural, Jira, Atlassian tools (or similar planning tools).

Preferred soft skill requirements:

• Ability to lead supplier-related projects.

Essential Function

• Must be able to maintain productive working relationships and treat fellow employees with respect.

Has contact with:

• Co-workers - to request information or services; to advise and solve problems.
• Assembly & inspection personnel - to provide direction with problem resolution.
• QA staff - to provide direction and technical leadership.
• Suppliers - including technical, purchasing, quality, engineering, sales personnel.
• Regulatory agencies (e.g. FDA, notified bodies).
• Interface with staff to perform internal audits.
• Interface with KARL STORZ manufacturing, engineering, marketing, sales, production departments to investigate CAPAs or product complaints and to communicate results of investigations and trends.
• Interface with all departments and project teams to exchange technical information.
• Interface with Operations departments to exchange process information.

Physical requirement/Demands:

• Manual dexterity for computer and electronic work is required.
• Ability to work on a computer for extended periods of time (approximately 8-10 hours per day).
• Physical ability to perform job requirements, such as, but not limited to: ability to lift approximately 20lbs.
• Ability to stand and walk for periods of time when participating in or hosting audits/auditors or at suppliers' locations.

Mental requirements/Emotional Demands:

• Ability to adapt and demonstrate flexibility in dealing with changing priorities and work situations.

Interpersonal and communication skills:

• Demonstrate a high standard of work ethic and professionalism to regulatory authorities, coworkers, and suppliers at all times.
• Represent the company in a positive and supportive manner at all times.
• A self-starter able to function independently with minimum direction and to act on behalf of the Supplier Quality Management in their absences.
• Ability to communicate effectively with personnel at all levels both verbally and in writing.
• Must be able to maintain productive working relationships with co-workers.
• Must treat fellow employees with respect.
• Must demonstrate a calm and rational disposition while remaining firm as required in dealing with others on issues of a controversial nature.
• Able to prepare written reports in a professional manner.
• Able to prepare and give presentations at all levels of the organization.

Core Requirements:

• Degree of accountability: Generally Independent
• Degree of decision making: Routine tasks, quality system strategic decisions
• Financial/Budgetary: Little or no financial impact on revenues or cost
• Safety: Adhere to KARL STORZ Safety protocols
• Quality: Adhere to KARL STORZ Quality Management System
• Supervision: The ability to work independently with minimal supervision
• Authority to Sign (not applicable for North America): N/A
• Travel: Up to 15% annually

Other duties consistent with the general nature and focus of the job and/or the goals and objectives of the department may be assigned.

Note for U.S. only: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.