Sr Quality Engineer

Job Summary

This position will be responsible for Supplier Quality in the Production Unit (PU). This position will ensure compliance to quality system requirements and drive the highest quality standards by helping to define specifications and by collaborating with suppliers. This role requires working in a cross-functional team environment with members of the R&D Design Centers, for example, as well as other members of the PU. This person applies engineering principles to resolve difficult problems, as well as plans, schedules, and completes assignments with minimal guidance.

Responsibilities

• Develops supplier quality requirements and production part qualification plans for design transfers of product into the manufacturing facility.

• Evaluates candidate suppliers to ensure that capabilities and systems align with capability and quality requirements.

• Conducts supplier audits of prospective and selected suppliers in accordance with established procedures.

• Leads technical investigations into non-conforming parts from suppliers, production, and customers.

• Develops and maintains local procedures consistent with company procedures and Quality Systems Requirements.

• Performs internal audits and participates in internal and external audit activities.

• Initiates and manages CAPA records, collaborates with other departments and cross-functional teams to support investigations and root cause analyses, and provides well-documented corrective and preventive action plans for identified issues.

• Develops statistical methods for tracking and trending requirements of products.

• Prepares product performance presentations and creates dashboard reporting for management.

• Leads process improvements and standardization of processes to ensure a lean manufacturing approach.

• Participates in quality activities including incoming inspections, non-conformance management, First Article inspections, and evaluates suppliers' process and product change requests.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

• B.S. degree in Engineering (Mechanical, Electrical, Biomedical preferred); CQE certification a plus.

• 3+ years of experience in a Medical Device (21 CFR 820) related industry. Supplier Quality, quality engineering and/or Product Development experience preferred.

• Working knowledge of lean manufacturing, Six Sigma, and Project Management principles a plus.

• Understanding and working experience with EN ISO14971, cGMP, ISO13485:2016, ISO9001:2015, FDA Design Control, document controls.

• Knowledge of quality control processes and statistical techniques.

• Understanding of manufacturing processes and techniques.

• Strong analytical problem-solving skills and attention to detail.

• Excellent verbal and written communication skills.

• Strong interpersonal skills and the ability to work with cross-functional teams.

• Works under minimal supervision on complex projects and may assist with cross-training less experienced peers. Strong project management skills.

• Experience with CAPA leadership and effective closure.

• Ability to travel 20%.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.