at APN Software Services Inc. in Newark, Delaware, United States
This position is for a temporary contract employee with expertise in navigating FDA regulated Quality Management Systems for healthcare product manufacturing. This position can work remotely and/or on site. 20 to 40 hours per week expected; varies with workload.
This individual will act in a supporting role to technical experts, and will conduct tasks such as reviewing qualification documents for accuracy and compliance; completing documentation required to validate processes and equipment while remaining compliant to the Siemens Healthineers Quality Management System; navigating SAP and Siemens’ Documentum suite; etc. The role may support Siemens’ auditors for audit responsibilities such as Supplier Quality Management System audits and Supplier Manufacturing Readiness Audits. Travel to/from suppliers and the Glasgow, DE site throughout the project may be required, with the opportunity to work from home when travel is not required. The role will have varying time commitment responsibilities, from zero to 40 hours per week, depending on project status. The position will augment activities such as those described above for the Glasgow Supplier Operations team.
-Ensures compliance with Siemens Healthineers' Quality Management System.
-Collaborates with internal stakeholders and suppliers and tool makers to meet or exceed business objectives.
-Works with project engineers to update and/or review specifications, FMEA's, technical evaluations, and other technical documents.
-Works within Siemens Healthineers’ systems, including SAP and Documentum, to ensure documentation is accurate and compliant. Exercises excellent documentation practices.
-Some travel may be required.
Required Skills/ Knowledge:
-Demonstrated ability to navigate and execute tasks within SAP.
-Strong familiarity with engineering documentation such as engineering specifications, engineering drawings, validation reports including (IQ, OQ, PQC) required for FDA-regulated manufacturing.
-Strong communication skills.
-Experience with CAPA, IR, and SCAR within healthcare product manufacturing environment.
-Experience conducting supplier audits.
-Demonstrated high level critical thinking and problem solving abilities with experience containing problems, conducting and documenting root cause, and identifying and executing solutions.
-Demonstrated ability to attain results while balancing technical solutions with business needs.
-Strong interpersonal skills with demonstrated ability to work across organizational boundaries, build networks, and collaborate in a team environment.
-Ability to act independently while managing complex and ambiguous tasks with minimal direction.
Required Education and Experience:
-Bachelor of Science, at minimum, in relevant field, such as mechanical engineering or biomedical science.
-Minimum 4 years experience working in FDA-regulated medical device/ pharmaceutical/ healthcare manufacturing environment and expertise in navigating the associated Quality Management System.
Preferred Knowledge/Skills, Education, and Experience
-Expertise in navigating Siemens Healthineers’ Quality Management system or similar Quality Management System such as pharmaceutical manufacturing, medical device manufacturing, etc.
-Experience working in FDA regulated environment.
-Experience working with products used in diagnostic or analytical laboratories.
-Experience managing suppliers.
-Strong working knowledge of statistics and design for manufacturing.
-Experience with plastics, injection molding, and materials engineering, including robust understanding of injection molding process validations (IQ, OQ, PQC) required for FDA-regulated manufacturing.
Qualified Applicants must be legally authorized for employment in the Unites States. Qualified Applicants will not require employer sponsored work authorization now or in the future for employment in the United States.
As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.