Quality Management System (QMS)
- Serve as the subject matter expert for the company on compliance issues. Provide guidance and support on matters relating to FDA/FBD/ISO regulations
- Responsible for maintaining appropriate regulatory documents for REACH, RoHS, and Conflict Minerals requirements.
- Coordinate ISO and customer audits. Coordinate FDB and/or FDA inspections if required.
- Responsible for directing the Promex Document Control function. Ensure all ECNs are reviewed for QMS impact.
Quality Assurance Management
- Manage Quality Engineers, Quality Assurance, and Quality Control activities
- Maintain records for customer complaints, NCMR, RMA, deviations, and CAPA.
- Work closely with Engineering and Operations to ensure that new processes being transferred to production meet customer and regulatory requirements.
- Monitor and report Key Performance Indicators (KPI’s) related to company quality objectives.
- Plan and manage the overall activities of receiving inspection and outgoing quality functions.
- Ensure timely resolution of supplier failures, supplier corrective actions and preventive actions.
Quality Engineering Management
- Manage the company’s risk management process to ensure the appropriate risk assessment is performed and documented.
- In conjunction with process engineering, conduct root cause analysis and implementation of corrective action for process and customer related concerns.
- Possesses or can obtain an IPC-A-610 and IPC-A-600 Certified IPC Trainer certificate.
Standardize inspection activities for package assembly operations using MIL-STD-883 internal and external visual requirements.
- Bachelor of Science degree in Engineering or related discipline
- Qualified (Exemplar Global) ISO 9001 / 13485 Lead Auditor is a plus
- 5 years’ experience in the medical products EMS industry.
- 2 years of direct supervisory/manager experience
- Proficiency in Microsoft Office Suite, Outlook email and database systems
- Strong knowledge of Quality Management Systems (QMS); particularly ISO 9001 and ISO 13485, 21 CFR 820, ITAR
- Considered a subject matter expert
- Must be well-organized with strong problem-solving skills.
- Excellent written and oral communication skills, solid organizational ability, negotiations skills with ability to drive cross functional teams.
- Strong mechanical spec interpretation skills
- Ability to define problems, collect data, establish facts, draw valid conclusions, and succinctly present data and information
- High level of proficiency in document control protocols
Prior experience working in a medical device contract manufacturing environment offering microelectronic assembly services