Site Quality Leader - QA/RA Manager ( Parkmore Galway)

The role of Quality and Regulatory Manager will primarily be responsible for;

• Developing and maintaining world class quality systems related to the development and manufacture of guide wires while developing employee efficiencies,
• Control of Quality Systems to ensure compliance to US FDA 21 CFR Part 820, MDD, AIMD, MDR 13485, Canada Medical Device Regulations, J-PAL and Brazil ANVISA.
• Establishment of Quality Objectives - tracking and reporting of the site's performance against these objectives.
• Act as the site Management Representative.
• Act as the site 'Person Responsible for Regulatory Compliance' (PRRC) per Integer PRRC Policy.
• Developing and leading a strong quality team to best-in-industry standards.
• Supporting the achievement of all day to day production targets
• Supervision of quality engineers to ensure compliance for their areas of responsibility for ;
  • implemented process controls,
  • assuring product quality,
  • qualification and validation
  • quality direction for NCRs, RCAs, technical issues related to regulatory queries,
  • supplier performance including incoming inspection process and supplier audits
• Supervision of documentation control personnel to ensure compliance for their areas of responsibility for ;
  • Plant change control and documentation control

::: Greatbatch

Medical

Lake Region EL:CTROCH:M

Brivant Ltd, TIA Integer International Research and Development Centre, Parkmore West Business Park, Galway, Ireland. Tel 353-91-385037

• Regulatory affairs through:
• Ensure regional compliance to all relevant regulations

• Be an active member of the R&D group design phase reviews if required in GLL & CHA for NRO products ensuring compliance to standards.
• Supervision of regulatory personnel to ensure compliance for their areas of responsibility for ;
  • Complaint handling

• Regulatory submissions.
  • Regulatory requests
  • Plant change control
• Customer notifications & sharing of technical information
  • Risk Management
  • Substantial/Significant change notifications to relevant Notified Body and Competent Authority

• Be an active member of the management team and work with all other managers and directors and staff to develop a world class lean manufacturing system.
• Constantly strive to deliver quality products in an environn1ent focused on throughput increase, inventory reduction and operational expense reduction.
• In addition, the Quality and Regulatory manager will be the company's Management representative and Regulatory Correspondent and will ensure that the quality system is established, implemented and maintained in accordance with ISO 13485 and he/she shall report on the performance of the quality system to senior management for review. This review will act as the basis for improvement. The Management Representative has the authority and responsibility for:

• Ensuring that the processes needed for the quality management system are

documented

• Reporting to top management, as define in the Management Review procedure, on the effectiveness of the quality management system and any needs for in1provement
• Ensuring the promotion of awareness of applicable regulatory requirements, quality management system requirements and customer requirements throughout the organization
• Liasing with external parties on matters relating to the quality management system
• Ensuring that the site complies with the quality management system
• Responsible for the release of products to market

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Employees are expected to support the quality concepts inherent in the business philosophies of Integer, including a variety of job related tasks which may not be specific to this position profile.

Accountabilities include:

Manage the site ensuring all sites comply with applicable external regulatory requirements. ensuring continuous compliance with the following:

FDA Quality System Regulation 21 CFR 820 (QSR)

Medical Device Directive

Medical Device Regulation

Health Canada Medical Device Regulations

ISO13485 Medical Device Quality Management System

ISO14971

Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards

Any other applicable market regulation

Set up a reporting structure to cover the sites which involves reporting on;

Regulatory Compliance.

Management Review & KPI system.

Complaint system.

Audit system (Internal Audit, Customer audits, Regulatory Audits, Corporate audits)

Documentation Control system

1. Regular audits of the scanned DMR

11. Ensuring timely and accurate processing of change requests and rework requests

111. Providing administrative support to Quality Dept. 1v. Ensuring upkeep of Archives

v. Control master labels

CAPA system.

Provide advice on regulatory affairs requirements for all proposed changes to device design. Act as regulatory affairs representative on product design and R&D redevelopment teams.

Compilation of regulatory submissions:

h. PMAs,

1. CE Mark registration,

510(k) registration,

Technical Dossiers and

similar applications and notifications

annual reports, supplements and registrations.

Ensure regulatory compliance of new products prior to market release. Ensure compliance of labelling, advertising and technical information.

Leading the preparation and direct all activities for:

FDA inspections,

ISO 13485 surveillance audits

Corporate audits

Internal audits Customer audits Customer complaint investigation, reporting, closure and trending. (see appendix 1 for details),

and follow through on close out of any subsequent actions assigned.

Ensuring continued compliance with DMR

Timely completion of departmental NCRs.

Updating related FMEAs as required.

Issuing and completing RCAs for connection and prevention of any related critical concerns or recurring issues.

Provide quality engineering support for ;

Technical queries relating to regulatory requests/compliance

Plant management review and KPI system

Plant NCRs and RCAs

Supplier issues

Develop and maintain a program ensuring only correctly validated equipment is used in

production process. This will include:

Participation in validation protocol development

Overseeing completion of validation or validation samples

Supporting the manufacturing engineering function to ensure compliance to related element of quality system.

Monitor production process for compliance to implemented process controls to

ensure quality product is shipped to customer and provide:

Trend analysis of data from the controls

Potential improvements for review with engineering based on the trends.

Areas for Improvement to senior management.

Review and propose changes to sampling plans based on trend analysis and changes to the system

Maintain and develop vendor quality management program consisting of

Development and establishment of new vendors

Dealing with all vendor non-compliances

Supporting the purchasing function to ensure compliance to related element of quality system.

Prepare validations, verifications, risk analysis and similar product assurance activities, ensuring test method validation are in place.

Compile and prepare technical infom1ation for customer distribution.

Maintain and develop the calibration, microbiological, sterilisation and environmental monitoring system

Liaise with Engineering dept. on new product development projects to ensure

All quality control requirements are clearly understood

Relevant process controls are documented and transferred to production and suitably implemented with necessary training.

Monitor all of above and provide reports on all of the above for senior management

Ensuring their direct reports play the required role in the plant annual objectives.

Responsible for the organisation, training and direct supervision of the relevant Quality engineers and indirectly for quality inspectors.

Ensure the company behavioral standards are adhered to, setting the example yourself for your direct reports.

Ensure all employees are briefed on a monthly basis.

Ensure open communication exists between the Quality department and all other groups in order to facilitate the speedy dissemination of relevant changes and improvements to both products and processes.

Prepare and control annual budgets for your department.

Work efficiently using own initiative, escalating decisions to the Quality Director as, when, and only when, necessary.

Ensuring backup and notification for any absences within the group, and being able to step down when required based on priorities.

Organization of work load of team based on priorities.

SKILLS AND KNOWLEDGE:

• Ability to communicate and work with people inside and outside the department.
• Strong interpersonal and communication skills.
• Competent in preparing written communication and correspondence.
• Ability to train and lead assigned employees.
• Ability to co-ordinate, plan and organise in a timely manner.
• Rigorous attention to detail.
• Proven track record in training and leading assigned employees.
• Ability to supervise, co-ordinate, plan and organise
• Rigorous attention to detail and organisation skills.
• Ability to work to deadlines and on own initiative.