Sr. Quality Systems Engineer - United States
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- An experienced engineering professional who works well in a cross-functional team environment.
- The individual will lead our efforts to attain and maintain Quality Management System compliance, as well as ensuring that we comply with applicable regulatory and statutory requirements.
- Must be able to work independently and independently resolve regulatory compliance and quality program related issues in a creative, high quality, timely and cost-effective manner. Core values must include commitment to customer excellence with demonstrated ethics and integrity.
Duties and Responsibilities:
- Independently audit/create/review/approve/release production Quality System documents/SOPs/work instructions as required, COs and Device History Records during device manufacturing, and communicate necessary changes to applicable department representatives to maintain compliance. Work with other departments to train and educate where necessary to ensure procedures are adequate.
- Support New Product Introduction projects as Quality Representative by performing the following activities: attend design & development team meetings; create/review/approve associated quality documentation [device master records, quality control plans, engineering/production risk analysis, labeling, engineering verification & validation results, production process validation results, and engineering change orders]; review design for quality improvements and manufacturing ease; support transfer of design to production; participate in pilot runs and review Process Failure Modes and Effects Analyses and provide feedback on effectiveness; ensure compliance to NPI procedures.
- Independently communicates within the project teams as well as Sr. Leadership through project reviews and status reports.Facilitates meaningful and constructive exchange of ideas and knowledge.Drives change in culture through ongoing training and education for project teams.
- Perform/supervise internal & external audits of applicable QSR/ISO processes and maintenance of applicable QSR databases to meet regulatory information tracking needs.Support Quality Team by addressing Audit Findings, Implementing CAPA, and updating Quality System documentation as needed.
- Perform/supervise investigations into product incident reports of internal (R&D, receiving, production, shipping) & external (customer complaints, service reports) adverse events, with emphasis on use of root cause and/or other analysis tools and verify effectiveness of implemented corrective actions to prevent recurrence of adverse events.Also, review internal and rework notifications/work orders to determine opportunities for corrective action. Includes review of Out of Box/Clean Instrument Failure metrics and implementing any associated corrective actions.
- Recommends process improvements and actively stays involved in the global development of processes and tools.Processes change orders to implement these improvements.
- Support insourcing projects as well as Continuous Improvement and LEAN projects as Quality Representative to ensure projects meet internal Quality requirements.
- Provides project direction and leadership in general quality program issues to support Quality Department effectiveness, in support of quality initiatives, and coordinate internal resources to ensure projects are complete and implemented on time. Recommend and implement enhancements to the Quality System that result in improved performance, increased customer satisfaction, and simplification of processes to reduce costs.
- BS (MS a plus) in Engineering and/or technical discipline, or equivalent, with minimum of five to eight years related experience and/or training; or equivalent combination of education and experience
- Experience with scientific instrumentation in a design and manufacturing environment; in either a quality, regulatory, design, or manufacturing role; within a medical device related company; or equivalent
- Lead Quality auditor, regulatory investigator, or equivalent status, and/or also with having performed internal process audits.
- Problem root cause analysis subject expert, verification & validation, flow mapping, and organizational and time-management skills.
Knowledge, Skills & Abilities:
- Computer proficiency with background in Agile and SAP business information systems a plus
- Working knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD).
- Energetic, results-driven with excellent organizational and prioritization skills.
- Excellent written and verbal communication skills and highly effective time management skills.
- Ability to operate independently and as part of a team
- Commitment to continuous improvement principles.