Quality Systems II Engineer

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Quality Systems II Engineer is responsible for supporting the site Quality Management System (QMS). Primary responsibilities include driving improvements to the QMS, having oversight of and ensuring compliance to the CAPA, NC and Quality Planning processes, and providing experienced quality assurance support to manufacturing and product development teams. This role will provide training on QMS processes to the organization, champion the QMS and work on many phases or sub-tasks of projects or entire projects.

This position is under the direct supervision of the Quality Engineering Manager. Works independently under general supervision, reviewed at project milestone and/or completion by senior management.

• Supports maintenance of the Quality management System, ensuring compliance with regulations and internal site and global procedures. Identifies gaps in the QMS and drives improvements to close gaps.
• Maintains the Quality Manual and site Quality System related procedures, ensuring contents are compliant and appropriate for the business.
• Identifies Noncompliance's, works with complaint handling, and CAPA Investigations.
• Organizes and manages the plant internal audit system as the site Internal Audit Manager.
• Supports external Quality System audits in key roles. Provides support and subject matter expertise during audits and inspections.
• Assists in the initiation, processing, and completion of CAPA records in the electronic system.
• Leads meetings and communications for CAPA updates, information, and concerns to keep CAPA timelines on track.
• Responsible for collecting and reporting Quality Metrics on regular basis in accordance with established procedures.
• Independently investigates, gathers data, and performs preliminary data analyses.
• Reports on Key Performance Indicators to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system.
• Provides experienced quality assurance support to manufacturing, product development teams, procurement, and other functional areas.
• Promotes the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), and Measure System Analysis.
• Keeps up with current and developing manufacturing and engineering trends that concern product quality.
• Undertakes special projects as required and contributes to continuous improvement activities.
• Supports and lead process improvement activities.
• Writes reports and presents progress at project meetings.
• Achieves goals within established budgets.
• Plans projects or subtasks so they may be tracked and presented.
• Attends various meetings and actions/communicates instructions and follow-ups.
• Independently determines approach for completion of assigned tasks.
• Coordinates and leads Quality Review meetings.
• Communicates confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.

• Bachelors in an engineering discipline recommended (Mechanical Engineering preferred) with minimum of 3 years’ experience in the medical device or pharmaceutical industry; strong analytical skills, exceptional writing and interpersonal relationship skills or combination of relevant work experience and education.
• Previous CAPA and/or quality systems/assurance experience and demonstrated use of quality tools/methodologies.
• Detailed knowledge of FDA Quality Systems Regulations, GMP, ISO 13485 and other global regulations and standards.
• Previous experience in high volume manufacturing environment.(Medical Device preferred)
• Demonstrated project management and leadership skills, including the ability to lead cross-functional project teams and resolve quality related issues in a timely and effective manner.
• Strong verbal and written communication skills with the ability to communicate effectively at multiple levels of the organization.
• Demonstrated organizational skills with the ability to multitask, prioritize and meet deadlines.
• Must be able to read and write in English.

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position

The job description does not constitute and employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change

$71,300.00 -…