We currently have an opportunity for a Quality Manager to provide oversight and support for local quality systems compliance & procedures, quality engineering support, and reporting on the health of regulatory compliance. The Quality manager will partner with functional managers to develop and maintain scalable, compliant systems and products.
Develops and delivers quality compliance strategy in alignment with global quality, divisional, business unit requirements and local and international regulations and standards.
Ongoing execution and improvements to the following quality system activities: Document Control Training Internal and External Quality System Audits Management Review Field Actions (recalls, corrections and withdrawals) CAPA System Nonconformance management Product holds
Monitors the performance of local quality systems (document control, training, CAPA, recalls/field corrective actions, corporate holds and audits) and report to management periodically on compliance health, inspection readiness and audit results.
Develops and implements a cross-functional internal & supplier audit program to ensure that all worldwide regulatory and global quality system requirements are implemented and met.
Represents the local quality system during regulatory and external inspections.
Manages local regulatory and external audits by providing the following activities: Pre-inspection readiness; Inspection activities; Post-inspection activities.
Drives QMS initiatives to ensure standardization throughout the organization.
Partners with and leads functional quality management to develop and maintain high performing, scalable and compliant quality systems.
Provides leadership and guidance for effective and timely communication and appropriate escalation of quality system issues to all levels of the organization.
Assures compliance to in-house and external specifications and standards.
Identifies and highlights quality issues by providing input to drive corrective actions to problems identified.
Performs / leads root cause analysis to determine corrective & preventative action(s), as necessary.
Assists with the investigation of root cause and determination of corrective and preventive actions relating to NCRs and CARs. Responsible for corrective action effectiveness verification after implementation of corrective actions.
Works continuous improvement projects from beginning to end. Characterizes the problem, identifies key process inputs, determines optimal operating window, implements controls to maintain output at desired level, and quantifies the improvement in savings, avoidance, or value.
Benchmarks across sites to identify and support strategic new systems, leverage resources, and expertise to develop and implement Best Demonstrated Practices
Develops proactive and collaborative working relationships across key disciplines
Bachelor’s degree in a life science, engineering, physical science or related discipline
10+ years of experience in medical devices or similarly regulated industry, including 5 years of experience in a medical device quality systems or engineering function
5+ years of experience serving as a quality system or engineering SME, including accountability for quality systems governance and inspection support with direct management is required.
Strong knowledge of quality system requirements with knowledge of the QSR, ISO, MDD, CMDR and MEDDEV requirements.
Lead Auditor or ASQ professional certification preferred (i.e. ISO 9001/13485 lead auditor, ASQ CQA, etc.)
Experience managing a department that provides complete product related data management to support product development, pre-production quality assurance, production and quality systems.
Ability to prioritize multiple high risk projects to ensure compliance with regulations and standard operating procedures.
Ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve team goals.
Strong written and verbal communication skills including collaboration and influencing skills at all levels.
In 1991, Bill Schmid and his wife Cathy suffered an unspeakable tragedy when they lost their infant daughter, Haley, to Sudden Infant Death Syndrome (SIDS), which is the sudden, unexplained death of a seemingly healthy infant up to an age of one year. After the loss of his daughter, Bill began an exhaustive review of the latest medical research and health recommendations for creating a safe sleep environment for babies to help ensure other families would not have to endure the same tragedy.
As a professional engineer, Bill devoted himself to finding new and creative ways to address sleep environment risks, which are primarily centered around loose bedding. Bedding can accidentally cover a baby’s face and interfere with breathing. With these risks in mind, Bill formed HALO Innovations and created the HALO SleepSack Wearable Blanket, which is intended to eliminate the likelihood that a baby can get entangled with clothing and loose bedding during sleep. The SleepSack wearable blanket is sleeveless and is worn over pajamas or a bodysuit to take the place of loose blankets. Since its launch, the HALO SleepSack brand has become the nation’s bestselling wearable blanket for babies and is widely used by hospitals nationwide.
To fulfill our mission, we listen, re-think, and use smart innovation to develop safer and better products for babies and children. This is most evident in the development of our Bassinest Swivel Sleeper for the hospital and at home. This revolutionary bassinet moves to allow parents to sleep close to their baby, while still maintaining a safe sleep environment for their child, reducing the risks associated with bed-sharing.