Quality Systems Engineer

Summary:

The candidate will be working with cross functional teams including production, suppliers, engineers, RMA technicians, and customers as required on various activities such as root cause analysis (CAPA), supplier qualification, developing and managing quality processes and KPIs, Document Control, ISO audits and compliance management and quality activities in general.. This individual will also provide support to our QC inspectors and Quality Assurance functions including the document control system. This role reports directly to the Quality Manager.

Essential Duties and Responsibilities include the following (Other duties may be assigned):

• Coordinate activities for 3rd party certification compliance as required by customers. Including but not limited to: Underwriter Laboratory (UL), Technischer Überwachungsverein (TuV), China Compulsory Certification (CCC), country specific certifications, etc.

• Manage the internal audit function and audit teams, create and manage audit schedules, develop audit plans, and complete final audit reports.

• Assist in all external ISO9001 audit activities including: Site audit preparation, liaison to the auditing body, ensure nonconformance's are addressed, and schedule the onsite audits.

• Oversee and manage training record administration. Set up training activities, retraining intervals, monitoring missed and overdue training with feedback to the department heads.

• Oversee and manage the ESD program.

• Oversee and manage calibration activities in Propel QMS software. Set up all instruments, define recalibration intervals, develop reports for upcoming calibration expiration, and develop mitigation activities for instruments found out of calibration.

• Assist document control activities in Propel QMS software. Create, review, and approve Engineering and Documentation Changes (ECO's and DCO's) as required.

• A key member of the MRB/MDR team in a disposition decision-making as well as CCB managing change control role.

• Conduct root cause analysis (lead or team member) using the 8D process for implementing effective and timely corrective and preventive actions.

• Contribute to the QMS Management Reviews.

• Manage the inspection functions and develop sampling and inspection plans.

• Work with supply chain on quality and other issues from suppliers to improve supplier performance and issue SCARs as appropriate to drive improvement.

• Assist in developing and supporting KPI and continuous improvement activities.

Essential Education, Training and Certification:

• Bachelor's Degree in Engineering

• Certified auditor (lead or internal) for ISO 9001:2015.

• Familiar with computer architecture; software, and firmware.

• Experience with ISO 9001:2015 internal and external auditing. Formal lead auditor training a plus.

• Functional knowledge of ISO-9001, ANSI ESD-2020, and other Quality Systems standards.

• Experience with RCCA/Problem Solving/Failure Analysis

• Proficient in MS Office

Skills & Qualifications:

• 5 - 7 years as a quality professional

• 3 years in a decision-making role

• Strong interpersonal and communication skills to establish effective working relationships with various departments within the company as well as with our customer and supplier bases.

• Thrive in developing results through team collaboration.

• Strong analytical skills; ability to compile complex data efficiently, and effective skills in hands on troubleshooting.

• Strong oral & written communications with excellent presentation and training skills

• Strong interpersonal and collaborative skills with the ability to interface with all levels of business, positively, effectively, and successfully.

• Utilizes visual management for problem resolution.

• Team-oriented with continuous improvement mindset. Lead cross-functional team members in constructive, productive, and a fair manner to resolve quality issues.

• Exhibits objectivity and openness to others' views; gives and welcomes feedback.

• Pay range: $70k-$100k