Statistical Process Control Manager

 

Main characteristics

Location

Shawforth, Lancashire

Company

GPW Recruitment

Salary

£40000 - £45000/annum +bonus + great benefits

Employment type

Permanent

Category

Manufacturing / Surveying

Job summary

Job title: Statistical Process Control Manager

Reference: E(phone number removed)

Location: Bacup

Start date: ASAP

Salary: To £45,000 pa + bonus + bens

Statistical Process Control Manager required for a specialist manufacturer of components and materials that are manufactured to high specifications for the medical industry.

Main purpose of the role as the Statistical Process Control Manager.

Perform statistical studies to support all new product introduction activities.
Undertaking and reporting of statistical studies within the area using Measurelink® and MiniTab® Analysis Software
Initiate and develop training and development plans for Quality personnel.
Establishing and revising existing policies and procedures in the area.
Continuous improvement of the process in the area to support all Quality standards, ISO 13485 & 21 CFR Part 820.
Identification of the appropriate measurement methods required for products being inspected.
Perform monthly trending of all NC's and non-conforming product that arise within designated production processes
Generate such data as is required for dashboard reviews as they apply to designated production processes
Where necessary, review, improve, update and approve Metrology methodology
Ensure all assigned quality actions are investigated, have causes identified and action plans completed to the agreed schedule, regardless of source
Lead investigations into product or process issues raised within designated production processes, identifying root cause and corrective action plans as required
Partner with Medical Machining and NPI team during the definition and introduction of new or improved processes, ensuring all validation, calibration, risk management and documentation activities are completed
Involvement in validation activities regarding IQ/OP/PQ completion
Support Manufacturing and Medical Machining teams to ensure that Preventive and Corrective Maintenance activities are completed to schedule.
Ensure that Critical System Changes are raised for all applicable changes
Work with Manufacturing and Medical Machining teams to ensure that process improvement activities including Lean Manufacturing activities are identified and introduced in a compliant manner
Ensure all activities are carried out with all regulations and laws governing business and quality operations and continuous improvement of the process in the area to support all Quality standards, ISO 13485 & 21 CFR Part 820.
Ensure compliance with all local, national, internal and company regulations, policies and procedures for Health, Safety and Environmental compliance

Key Accountabilities as the Statistical Process Control Manager.

Maintaining and developing the Quality Management System
Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes
Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence
Review, discuss and complete FAI requirements for new products
Ensure pFMEA's, Control Plans, Process Flows are completed and reviewed as required
Develops sampling plans by applying attribute, variable, and sequential sampling methods
Analyses data by completing hypothesis, normal distribution, and process capability analysis tests
Prepares reports by collecting, analysing, and summarizing data; making recommendations
Contributes to team effort by completing related results as needed
Has involvement in the companies validation requirements
Ensuring measurement systems are appropriate for the
Directs engineering and quality personnel in design, manufacture, evaluation, and calibration of measurement standards, instruments, and test systems to ensure selection of approved instrumentation.
Advises others on methods of resolving measurement problems and exchanges information with other metrology personnel.
Ability to communicate sound metrology principles and knowledge to other metrology employees and leadership

Key skills, knowledge and experience required by the Statistical Process Control Manager

Technical degree in Engineering or similar Scientific discipline; Bachelor's Degree preferred.
Experience in a similar role
Quality Management System and Techniques
Supervisory and/or managerial experience in operating and understanding a metrology operation.
International & British Quality Standards (ISO 13485, ISO 17025, ISO 14001, BS OHSAS 18001, FDA, QSR's and Medical Devices Directive)
Good Manufacturing Practice
Quality toolbox including FMEA, Process flows, Root cause investigations, Lean and Six Sigma tools & techniques
Knowledge of statistical software Measurelink ® & MiniTab Analysis ®
Validation requirements (IQ, OQ, PQ)
MSA & GR&R experience
Knowledge of Metrology techniques with Mitutoyo CMM programming experience being advantageous
Document and maintain records accurately
Previous experience in similar role
Strong understanding and ability to use statistical analysis tools
Good verbal and written communications skills

Hours of work are Monday to Thursday 08.30 - 17.00, Friday 08.30-13.30 (35 hour working week), which includes breaks.

Salary and benefits on offer as the Statistical Process Control Manager

Salary to £45,000 pa depending on experience
Enrolment onto Wellness app once probationary period completed (can swap coins earned for vouchers)
Policy to claim back medical expenses (employees covered, additional cover paid by employees)
Holidays: Annual holiday entitlement is 32 days including 8 statutory public holidays
Long Service Days
Bonus: Annual productivity bonus for all employees if targets are met but
Cycle to Work Scheme
Savings Club
Employee Assistance Programme

Benefits: bonus + great benefits