Sr. Quality Engineer

Job SummarySalary Range: $85,000 to $95,000 Per Year
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.
Please note: This position does not support employment sponsorship, either now or in the future. Candidates must be legally authorized to work in the United States at the time of application and remain so without the need for current or future visa sponsorship.
Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
This position will be responsible to help ensure compliance to the quality system requirements and standards (FDA, EU, Health Canada, ISO 13485), analyze product quality performance and drive the highest quality levels through applying engineering principles to solve difficult problems cross-functionally with our key internal stakeholders, and utilizing best-in-class quality engineering practices.

Responsibilities

1) Provide Quality support for the organization’s product development initiatives and manufacturing operations by performing the following:

• Ensuring design transfer compliance through active team membership
• Ensuring quality compliance to the change order process
• Providing quality engineering support for device manufacturing

2) Utilize engineering principles, technical analysis, computational analysis, and problem-solving tools to drive resolution of quality issues.

3) Lead technical investigations into non-conforming parts from production and from customers in a cross-functional environment

4) Develop and maintain local procedures consistent with parent company procedures and Quality Systems Requirements

5) Prepare product performance presentations and creates dashboard reporting for management

6) Lead process improvements and standardization of processes to ensure a lean manufacturing approach

7) Participate in quality activities including incoming inspections, non-conformance management, First Article inspections, and assist in evaluating 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

• Bachelor’s Degree in Engineering (Mechanical, Electrical, or Biomedical preferred).

• Strong proficiency with Microsoft Word, PowerPoint, Excel, Minitab or other statistical software

• Strong / demonstrated attention to detail

• Strong / demonstrated project management skills

• Ability to work as a collaborative team member

• Excellent verbal and written communication skills

• Strong analytical, trouble-shooting and problem solving skills

• Bachelor degree in engineering field (Mechanical, electrical, electromechanical preferred)

• Experience and familiarity with quality tools and respective methodology (SPC, PFMEA, Control Plans, 6-sigma, 8-D, DOE)

• Lead a proactive role to continuously improve processes and systems. 

• Ability to mentor new associates and other team members. 

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 contribution, 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.