Q.C. Manager

Job Description

C&W Swiss, Inc. is seeking to add a Q.C. Manager to our team. C&W Swiss manufactures precision medical instruments, spinal implants, and bone screws using Star Swiss Style CNC lathes. We are a family-owned machine shop that has been in business for 25 years, operating first shift only. If you work for C&W Swiss you will be a name not a number, in our clean, well lit, climate-controlled facility.

Essential Duties and Responsibilities:

The Quality Manager is responsible for ensuring that all quality related policies and procedures are adhered to and carried out on an ongoing basis as well as reviewing the adequacy and effectiveness of the Quality System procedures by doing the following:

• Manages the Quality Management System (QMS) and controls QMS documentation
• Implement procedures for dealing with non-conformities, monitoring nonconformity reports, executing corrective actions, and documenting all corrective/preventative actions in response to audit findings
• Execute ongoing training of employees on QMS or process changes, quality alerts, and quality standards
• Responsible for evaluating effectiveness of training to ensure completion and accountability
• Develops and executes standards and methods for inspection, testing, and evaluation
• Responsible for auditee role in quality audits
• Communicate with management for Management Review meetings and present the internal audit reports/findings
• Monitor compliance and adequacy of procedures to ensure ongoing continuous improvement in processes and procedures
• Applies Statistical Process Control (SPC), modern quality tools such as DOE, and Failure Mode Effects Analysis (FMEA), 5-S, and Six Sigma methods for analyzing data to evaluate current processes and recommended adequate changes in processes
• Reviews all data obtained during quality control and quality assurance activities to ensure consistency with company policies and procedures, and expected quality standards
• Develops new approaches to solve problems identified in quality activities
• Communicates significant issues or developments identified during quality activities and actions being taken to improve, including status of QMS, product compliance, system audits, and corrective action plans
• Responds directly to customer complaints including initiating product return, setting up containment or providing third party assessment
• Direct workers engaged in inspection and testing and testing activities to ensure continuous control over materials, facilities, and products
• Serves as principal customer interface with respect to quality issues and customer satisfaction opportunities; escalates resolutions of customer issues
• Investigates and resolves customer quality issues and non-conformances; issues to appropriate department and implements countermeasures to avoid repeat issues
• Verifies corrective and preventative actions are implemented
• Manages MRB disposition of non-conforming products
• Performs Return Product Analysis and opportunities
• Coordinates QMS records retention system for company
• Participates as a member of the management team in reviewing company QMS and its effectiveness including Lean, Six Sigma, and other continuous improvement activities
• Manages the management review process
• Directs or participates in cross-functional teams in the development, implementation, and maintenance of the QMS
• Maintains working knowledge of government and industry quality codes and standards
• Lead by example in following company policies, procedures, and expected standards of quality, safety, and continuous improvement
• Mentor, train, and guide quality employees in meeting objectives of QMS
• May perform other duties as assigned
  
  

Minimum Job Requirements

• ISO 13485:2016 Standard Experience
• Previous experience working in medical manufacturing
• Experience with JobBoss software or similar MRP systems.
  
  

Job Type: Full-time

Pay: Negotiable

Benefits:

• Medical
• Health Savings Account
• Life Insurance
• Dental
• Aflac
• 401K
• Supplemental Insurance
• Paid Time Off (PTO)
• Holiday Pay
  
  

Schedule:

• Monday to Friday: 7AM - 4:30PM
  
  

Education:

• High School Diploma or Equivalent
  
  

Experience:

• Quality Management: 5 years (Required)
  
  

Ability to Commute:

• Englewood, OH 45315 (Required)
  
  

Ability to Relocate:

• Englewood, OH 45315: Relocate before starting work (Preferred)
  
  

Work Location: In person

• You must be able to pass a background check. We are looking for sexual crimes, violent crimes, and crimes involving theft. *
  
  

Company Description

C&W Swiss is a precision medical manufacturing machine shop, manufacturing bones screws, spinal implants, and other medical components using Star swiss CNC lathes.

C&W Swiss is a precision medical manufacturing machine shop, manufacturing bones screws, spinal implants, and other medical components using Star swiss CNC lathes.