The Quality Manager (QM) is the quality leader of the organization. Responsibility for the quality of the product and the performance of the quality system resides with this individual. The QM has a direct hand in the day to day operation of inspection activities, including the performance of inspection, calibration and maintenance of measurement equipment, reporting to all levels of the organization on product performance and establishment of resources. Additionally, the QM is responsible for the over health of the quality system, including compliance to all applicable industry and market specifications. This responsibility includes the strategic planning for the quality system including design, implementation and improvement activities. As the quality leader at the organization, this individual is responsible for exemplifying the quality culture, encouraging and soliciting continuous improvement activities in all areas and functions at the organization. The QM needs to be the go to resource on all issue of quality and must provide consistent interpretation and execution of policies. In the performance of these responsibilities, business metric and accounting principles need to be applied and incorporated to understand the cost of quality implications of decisions.
Relationships & Communication:
VP of Operations
· Quality Inspector(s)
· Quality Engineer(s)
All Functions, all personnel
Customers / Suppliers / Regulatory Groups
Qualifications: The employee in this role should have some or all of the following characteristics/qualifications:
Bachelor’s degree in Engineering or Technical field
Internal Quality Auditor (ASQ or IRCA certified a plus)
Advanced Degree (Quality)
Strong knowledge of ISO9001:2015 and previous versions
Quality Tools, Improvement tools (such as 6 sigma, SPC, DOE)
Internal Auditing, CAPA management, metrics, planning, project management, Customer complaints, customer response and feedback
5-10 years of quality experience in a manufacturing environment (QC, QA, or Inspection)
3-5 years in a leadership role
Internal Auditing, MRB, MRM
5 years of experience on ISO 9001implementation and or auditing
Skills and competences:
Strong Computer skills
Excellent verbal and written communication skills, with a good ability to mediate, build consensus and resolve issues in a calm and coordinated way.
Strong communication and listening skills
Methodical approach to problem solving along with an unflappable commitment to quality are a must.
Attentive to detail without losing sight of the big picture
Process oriented and metric driven
Essential Responsibilities: The following list highlights the key responsibilities/tasks.
· Manage, prioritize and participate in inspection activities as needed (Incoming, WIP & Final)
- Provide advice on Measurement techniques as well as precision and accuracy
- Keep up to date on new technology, evaluate and recommends new equipment as needed
· Analyze and report on product quality performance to all levels of the organization
· Continuously review and update quality systems and procedures compliant with ISO 9001 standard
- Maintain the group of Quality Representatives up to date on Quality RTools.
- Assist each department on Quality System implementation as well as provide help on quality issues as needed.
· Analyze and report on quality system health to all levels of the organization
- Encourage, direct and facilitate continuous improvement activities
- Manage and maintain the Corrective and Preventative Action Systems.
- Manage the procedures that deal with handling customer complaints and RMA issues.
- Provide internal consulting on quality related concepts including but not limited to: design of experiments, statistical analysis, problem solving, quality tools and metrology.
- Review resource and quality training deficits with department heads and facilitate the implementation of training activities.
- Manage and administer internal auditing program to confirm compliance of systems to customer and specification requirements.
- Support Purchasing on vendor quality issues with direct vendor involvement
- Travel to Vendor sites to asses vendor capabilities
- Perform vendor audits in cooperation with Purchasing
- Manage the Supplier Corrective Action System
- Assist Purchasing on supplier evaluation and metrics
- Participate on MRB as needed
- Responsible for running Audits of the CTECH quality system by customers and/or third parties.
- Respond to customer complaints on time
- Complete Quality Agreements as requested by the customer
- Keep up to date on Regulatory requirements (USP, EP , JP, etc) and verify compliance as per internal protocols.
- Complete Customer’s Questionnaires on time
- Support Sales on customer quality issues with direct customer involvement
- Assist sales in product specification as related to quality concerns
- Travel to Customer sites as required
· Lead the uncertainty project and coordinate all activities associated with the uncertainty calculation
· Provide training to team members accordingly
· Define and outline a Plan to implement the calculation of uncertainty for the different products
· Execute the plan accordingly
· Report the results quarterly per product Line