Maioha Mai Watene
Hamilton,New Zealand
Summary
Detail-oriented Quality Manager offering 20+ years of expertise in implementation and management of Quality, Laboratory, H&S and Environmental ISO Standards with advanced knowledge of risk management, policy development and regulatory compliance with a proven track record of partnering with executives and business leaders to identify vulnerabilities and create corrective actions. Flexible, adaptable, ethical, and high energy leader with superior communication, relationship management and influencing skills. Proven ability to define problems, collect data, establish facts, and draw conclusions. Focused on driving staff in meeting customers' needs and implementing changes by supporting strategic initiatives.
Overview
22
22
years of professional experience
1
1
Certification
Work History
Quality Manager
Cospak Limited
01.2024 - Current
- To improve and establish a Quality Management system compliant with ISO 9001:2015
- Guiding and assisting Senior Management to understand their responsibilities regarding the Quality Management System and their responsibility to ensure all elements of the standard are being addressed including identifying risks and opportunities, setting Quality objectives, and ensuring they are aligned with the global quality policy
- Manage the Quality Control laboratory and QC Technicians
- Ensuring all test requirements are conducted as per the appropriate Standard Operating Procedure
- Ensure all results are recorded and any abnormalities highlighted to the production and technical teams
- Managing all customer complaints, internal and supplier non-conformances including investigating all thoroughly
- Implementing team strategies dependent on severity by using Fishbone diagrams or using 5 Why’s, with an outcome of establishing a robust corrective or preventative action
- Implement and conduct training of each element within the ISO9001:2015 standard to all staff, particularly document control, non-conformances, and continuous improvement
- Manage all internal audits and internal auditors are utilized as per the Cospak Quality Systems and as per ISO9001:2015 standard
- Manage and conduct supplier audits as per the Cospak Approved Supplier Program
- Assisting the operations and warehouse teams to establish written procedures and training of the procedures with their staff
Group Quality Manager
ES Plastics Ltd
09.2022 - 12.2023
- Company Overview: ESP Medical & Laboratories
- To ensure the Quality Management, Laboratory and Health & Safety systems of ES Plastics Ltd operate efficiently and in accordance with current legislation and the applicable requirements of ISO9001:2015, ISO13485:2016, MPI AVCM requirements, GMP, ISO 17025 Medsafe standards and Health & Safety at Work Act 2015
- Monitor the effectiveness of the QMS by reporting and addressing customer complaints and all internal failures and implementing corrective actions to prevent recurrence
- Play an integral role in identifying continuous improvement practices within our manufacturing processes, products, tools, and services
- Lead and implement risk management processes to identify potential risks to products, processes, business, and systems
- Attend monthly Management meetings to communicate all quality, laboratory, health & safety, and environmental issues
- Conduct 6 monthly Quality meetings with other Senior management to discuss and review the Quality Policy and Quality Objectives are adequate and measures are on target
- Write and implement all Standard Operating Procedures relating to Quality, Laboratory and Health & Safety Systems
- Ensure training of all Quality staff, Machine Operators and Production Supervisors in Quality and Health & Safety Standard Operating procedures is conducted and current
- Play an active role in inducting new employees and ensuring they are made aware of all necessary health & safety processes and safe work practices
- Implement quality plans and quality specifications for new products in accordance with customer requests and ensure test parameters are within process parameters
- Be the lead representative for ES Plastics Ltd, ESP Medical, ESP Laboratories and Cuemate (veterinary delivery devices) during all regulatory and customer audits
- Responsible for communicating all audit responses back to regulatory bodies
- Conduct internal audits as per Quality Management Systems for each standard ES Plastics, ESP Medical and ESP Laboratories are certified to and training potential personnel to an internal auditor status for each of the regulatory requirements
- ESP Medical & Laboratories
QA Manager & H&S Representative
Datamars
09.2013 - 08.2022
- Manage quality assurance program, including on-site evaluations, internal audits, customer audits and supplier qualifications
- Oversee and manage Inwards Goods and Finished Product Test Laboratories and Technicians to ensure raw materials and finished product met critical test specifications and all non-conforming products were managed accordingly
- Work closely with Operations, R &D and Sales senior management team to maintain optimum levels of communication to effectively and efficiently complete projects
- Develop and implement performance improvement strategies and plans to promote continuous improvement
- Prepare Technical reports requested by customers, Certificates of Analysis and Certificates of Conformance to support all test requirements for finished products
- Identified issues, analyzed information, and provided solutions to problems
- Manage team of 4 employees, overseeing hiring, training, and professional growth of employees
- Report production non-conformities to departmental managers and production supervisors
- Led ISO 9001 implementation certification effort and provided training to all employees
- Establish and track quality department goals and objectives
- Collaborate with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans
- Develop quality planning for multiple new product launches by verifying customer requirements and implementing them in design and production
- Implemented ISO 9000:2015 quality systems, defining business practices, leading to certification and improved business practices
- Schedule and chair quality review meetings to review effectiveness of performance mitigating risk, improving throughput, and achieving customer satisfaction
- Track quality issues with external customers, suppliers, and internal plant operations
- Use critical thinking to break down problems, evaluate solutions and make decisions
- Keep operations in compliance with HSWA 2015 through regular safety inspections and hazard management strategies
- Be responsible for all H & S documentation including policies and SOP’s and ensure they are current and appropriate
- Have an integral role in conducting site inductions of new staff members and contractors
- Be an active member of the H & S committee and conduct/ organize all safety training requirements
- Maintain risk management policies and monitor compliance to control company liability
- Maintain effective working relationships with regulatory authorities, suppliers, and customers
QA Associate
DEC Pharmaceuticals
09.2012 - 09.2013
- Generated quality control reports for returned products to identify and communicate patterns
- Supported audit preparation through research, analysis, and presentation development
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies
- Collaborated with Quality Manager to write procedures for QC unit and health & Safety
- Managed customer complaint investigations to improve quality and Continuous Improvement processes
- Developed corrective action plans in conjunction with Quality Manager to improve the overall quality of product and service
- Maintained Quality and lab records for compliance and analysis purposes
- Monitored product standards and quality-control programs
- Provided analytical, planning and coordination support on projects as assigned, reviewing, interpreting, analyzing, and illustrating data to stimulate and support enlightened decision making
- Verified consistency in quality planning, quality control, quality assurance and quality improvement
- Reviewed documents, files, transcripts, and other records to assess compliance and potential risk
- Played an active role in managing change control from inception to completion
Quality, Laboratory and Health & Safety Manager
New Zealand Food Industries
11.2006 - 08.2012
- Managed and oversaw all laboratory operations, budgets, test cost analysis and laboratory staff
- Implemented and conducted training for all laboratory technicians
- Analyzed all microbiological and chemical test results for accuracy and raised any out of specification results or abnormalities to management with recommendations on how to proceed further
- Inspected outbound shipments and conducted random sampling of products for shelf-life testing
- Recorded defects and coordinated issue resolution with development team and functional leads
- Managed full life cycle of assigned audits in alignment with departmental procedures, delivering progress as well as closing reports to senior management and clients
- Managed quality programs to reduce overdue compliance activities
- Verified consistency in quality planning, quality control, quality assurance and quality improvement
- Played a major role with implementing processes and procedures to meet WQA (Woolworths Quality Assurance) certification
- Maintain adherence to ISO9001:2008 certification and continually investigate and implement improvement practices to our Quality Management System
- Collaborated with external training providers to facilitate personnel compliance training
- Publicized health and safety program requirements and mentored employees on critical nature of compliance
- Advised division leaders of regulatory risks in business processes and provided recommendations for improvement
- Played instrumental role in company-wide risk assessment efforts, supporting enhancements in business processes and controls
- Delivered subject matter expertise for internal and external customers on compliance best practices and quality control
- Maintained effective working relationships with regulatory authorities, suppliers, and customers
- Monitored production operations for compliance with specifications and promptly reported defects
- Developed checklists to coordinate workplace inspections with departmental managers
- Managed and maintained H & S systems, documentation to ACC (WSMP) standards
- Implemented and was instrumental in developing a site induction program which captured employee and contractor management
- Performed regular visual inspections and safety audits to identify any compliance issues
Specialty Microbiology Coordinator
Fonterra Waitoa
10.2002 - 11.2006
- Executed corrective actions when test controls were outside specified limits
- Maintained confidentiality of all test information to conform to internal, external and customer regulatory standards
- Kept laboratory equipment clean and in good working order for optimal functionality and longevity
- Utilized expertise in microbiology, to help with bacterial diagnosis
- Played an integral role in developing a rapid test method for use in production to identify Enterobacter Sakazakii (a pathogen found in infant formula and detrimental to premature infants)
- Handled specimens according to laboratory protocols to maximize accuracy and precision of results
- Carried out day-day-day duties accurately and efficiently
- Develop and implement key performance measures by the microbiology lab, i.e., test turnaround times
- Used critical thinking to break down problems, evaluate solutions and make decisions
- Managed team of 36 employees, overseeing hiring, training, and professional growth of employees
- Ensure all Health and Safety practices were adhered to by laboratory staff
Education
National Diploma of Business Level 5 - Business and Strategic Management
Te Tai Poutini Polytechnic
West Coast, New Zealand06.2011
Bachelor of Science - Microbiology and Biological Science
University of Waikato
Hamilton, WKO04.2002
New Zealand Certificate of Science -
Wintec
Hamilton, WKO11.1999
Skills
- QA methodologies mastery
- Organized managerial style
- Excellent attention to detail
- QA Management
- Audit Support
- Conducting investigations
- Internal and External Audits
- Excellent documentation management
- Regulatory compliance
- Product Recall Process
- Compliance documentation
- Systems development
- Food Safety Compliance
- Health, Safety & Environmental Compliance
- Information gathering
- Customer Complaint Management
- Vendor / Supplier Performance Management
- Risk analysis and assessment
- Validation Processes ie, URS, IQ, OQ, PQ
- Computer proficiency
- Database Management
- Recordkeeping
- Employee supervision
- Excellent written communication
- Relationship-Building
- Cultural awareness
- Analytical skills
- GMP
- ISO9001:2015
- ISO17025
- RMP
- FSP
Accomplishments
- Supervised team of 11 staff members.
- Documented and resolved > 1000 issues which led to a decrease in non-conformances and increase in good quality product and improving good customer relationships.
Certification
- CQM - Certified Quality Manager
- Lead Auditor ISO 22000 FSMS Certificate
- Internal Auditor Certificate for Integrated Systems: ISO9001:2015, ISO14001:2015, ISO45001:2018
- Food HACCP Certificate
- HAZOP Leader Certificate
- NZ Certificate in Workplace Health & Safety Practices Level 3
- NZ Certificate in Workplace Health & Safety Practices Level 4
- H & S Representative (Levels 1, 2 & 3) Certificate
- ICAM Awareness Certificate
- Safety Leadership for Managers Certificate
- Full Drivers Licence Class 1
Additional Information
Further work history is available upon request.
Timeline
Quality Manager
Cospak Limited
01.2024 - Current
Group Quality Manager
ES Plastics Ltd
09.2022 - 12.2023
QA Manager & H&S Representative
Datamars
09.2013 - 08.2022
QA Associate
DEC Pharmaceuticals
09.2012 - 09.2013
Quality, Laboratory and Health & Safety Manager
New Zealand Food Industries
11.2006 - 08.2012
Specialty Microbiology Coordinator
Fonterra Waitoa
10.2002 - 11.2006
Bachelor of Science - Microbiology and Biological Science
University of Waikato
New Zealand Certificate of Science -
Wintec
National Diploma of Business Level 5 - Business and Strategic Management
Te Tai Poutini Polytechnic
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