The Quality Manager is a pivotal role in the company’s quality and ISO initiatives. Reporting to the Chief Commercial Officer, this individual will work closely with internal personnel in operations, engineering, regulatory compliance, and field service, while working externally with customers and suppliers as needed. Specifically, this individual will be responsible for becoming Proveris’s ISO 9001:2015 certified quality management system’s champion, conducting quality audits, updating documentation as needed to 2015 standards, and assuring up-to-date employee training on relevant quality procedures. In addition, this individual will be responsible for the company’s regulatory compliance, driving ECO and CAPA processes, incoming inspection, as well as working with manufacturing and engineering personnel in a quality oriented capacity.
Essential Duties and Responsibilities:
- ISO – serve as ISO Champion (i.e, responsible for conducting internal audits, SOP maintenance, personnel training on relevant quality procedures, and change implementation).
- Responsible for initiating CAPA and managing quarterly CAPA effectiveness reviews.
- Regulatory Compliance – assume project management role for regulatory requirement projects, and identify and monitor regulatory requirements (e.g. RoHS, WEEE, etc).
- Provide data analysis and techniques to improve process efficiency within the company’s operations.
- Interact with quality suppliers to specify component requirements and provide any root cause corrective actions from suppliers.
- Responsible for creating and maintaining incoming/outgoing product and process inspection/testing procedures.
- Incoming Inspection – perform incoming inspection as required, create and review incoming inspection procedures, manage the review approval process, and work with manufacturing to ensure incoming inspection procedures are effective and efficient.
- Manufacturing – manage and monitor calibration processes and ensure all equipment is calibrated as required. Create and drive subassembly, system and final release testing protocols.
- Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Review and approve in-process and outgoing test methodologies for Proveris instruments.
- Product Management – Tract, review, prioritize and drive product improvements on existing products with Product Management.
- Work with Purchasing to manage supplier quality metrics and to resolve supplier quality issues with root cause corrective action plans.
- Engineering – participate in weekly meetings, create required ECO’s, and provide quality planning for current and future products.
- Service – Create, review and manage the quality processes related to the company’s servicing activities.
- Management – Create and drive quarterly product quality review on incoming inspection, manufacturing, and service metrics, ECOs and key issue resolution.
- 5-8+ years of hands-on quality engineering environment including software and instruments, in an internationally recognized quality management system (i.e. ISO9001, or cGxP) environment.
- Proven experience working with low-volume/high-complexity instrumentation intended for use in regulated environments (e.g. cGMP for pharmaceutical products).
- Some level of ASQ certification, is desirable.
- High level of proficiency with Microsoft Word, Excel, PowerPoint, Visio, Outlook and Mindjet MindManager.
- Strong hands-on hardware and software troubleshooting skills.
- Excellent time/task management, interpersonal, communications, and writing skills.
- “Hands on” personality with a proven ability to work effectively in a focused, team oriented environment.
- Proven ability to multi-task in a fast-paced environment.
- Attention to detail is a must.
- Desire to be part of a growing, fast-paced company.
- Strong willingness to learn new skills, systems, and customer requirements.
Education and/or Experience:
- Minimum of 5 years working as a Quality Manager or related function.
- Minimum of a Bachelor’s degree or work experience equivalent in an engineering, science or technology oriented discipline.
Qualified candidates should submit resumes to: email@example.com
Local candidates only – no relocation is available for this position.
Proveris Scientific is an Equal Opportunity Employer.