QUALITY OPERATIONS ENGINEER - Katalyst Healthcares & Life Sciences
Northern, NJ 07601
About the Job
Responsibilities :
- Oversight and leadership of the non-conforming product, deviation, and MRB processes.
- Review/approve Device History Records, Nonconformances, Deviation, and other product related records.
- Review/approve routine facility, equipment, and environmental monitoring reports Identify and lead continuous improvement and lean opportunities for Quality Operations and related processes including developing and updating related procedures and forms.
- Maintain tracking and trending files for assigned QMS elements and generate status reports as needed.
- Perform Internal Audits and support External Audits (government agencies, notified body, etc.)
- Cross training and backup of other QMS elements as needed.
- Assist with various special ad hoc projects and other duties as assigned.
- Integrity - We act in all ways with respect and transparency, ethically and honestly, with everyone.
- Our work represents who we are, as we create products we can proudly recommend to our loved ones.Creativity - We are passionate trailblazers, relentless in our pursuit of continuous improvement.
- Collaboration - We are only successful together, operating as one diverse and inclusive team with each other and our customers.
- Determination - We are passionate, dedicated, and tenacious about our goals.
- Moved by Urgency - Patients depend on us delivering our products with enthusiasm, efficiency, and diligence.
- Our obligation and privilege is to drive urgency on patients' behalf Physical Demands.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is occasionally required to stand, walk, sit, and file records.
- The employee must occasionally lift or move office products and supplies, up to 50 pounds.
- Regular travel between local sites may be required. Travel for off-site training or supplier audits may be required.
- This position does not manage staff but does oversee associated programs.
- B.S. in engineering or an alternative bachelor's degree program plus approximately 5 years of experience in a Quality Engineering role, or an equivalent combination of education and experience.
- Certification as a quality engineer (CQE) and/or quality auditor (CQA) is preferred.
- Green Belt, Black Belt, or other continuous improvement certification is highly desired.
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Fundamental understanding of QSR/ISO regulations (ISO 13485 and 21 CFR 820).
- Exceptional problem-solving skills including ability to apply risk analysis (e.g. FMEA), error proofing, process control, and process capability methods to process improvements.
- Ability to listen and clearly communicate verbally, in writing, and in person to people at various levels of the organization.
- Ability to prioritize and multitask in a high energy fast-paced environment.
- Software knowledge including Microsoft Word, Excel, and PowerPoint.
Source : Katalyst Healthcares & Life Sciences
