Quality & Regulatory Manager Job Description
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,
· 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 ;
o implemented process controls,
o assuring product quality,
o qualification and validation
o quality direction for MRRs, RCAs, technical issues related to regulatory queries,
o supplier performance including incoming inspection process and supplier audits
· Supervision of documentation control personnel to ensure compliance for their areas of responsibility for ;
o Plant change control and documentation control
· Design Assurance through:
o Development and maintaining product test methods.
o Validation of product test methods to meet industry and regulatory standards.
· 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 ;
o Complaint handling
o Regulatory submissions.
o Regulatory requests
o Plant change control
o Customer notifications & sharing of technical information
o Risk Management
· 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 environment focussed on throughput increase, inventory reduction and operational expense reduction.
· In addition the Quality and Regulatory manager will be the company’s Management representative 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. .
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Employees are expected to support the quality concepts inherent in the business philosophies of our client including a variety of job related tasks which may not be specific to this position profile.
Accountabilities include:
1. Manage the site ensuring all sites comply with applicable external regulatory requirements. ensuring continuous compliance with the following:
a. FDA Quality System Regulation 21 CFR 820 (QSR)
b. Medical Device Directive
c. Health Canada Medical Device Regulations
d. ISO13485 Medical Device Quality Management System
e. ISO14971
f. Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
g. Any other applicable market regulation
- Set up a reporting structure to cover the sites which involves reporting on;
- Regulatory Compliance.
- Management Review & PMR/KPI system.
- Complaint system.
- Audit system (Internal Audit, Customer audits, Regulatory Audits, Corporate audits)
- Documentation Control system
i. Regular audits of the scanned DMR
ii. Ensuring timely and accurate processing of ECOs and rework requests
iii. Providing administrative support to Quality Dept.
iv. Ensuring upkeep of Archives
v. Control master labels
- CAPA system.
- Preventative system.
3. 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.
4. Compilation of regulatory submissions:
h. PMAs,
i. CE Mark registration,
a. 510(k) registration,
b. Technical Dossiers and
c. similar applications and notifications
d. annual reports, supplements and registrations.
5. Ensure regulatory compliance of new products prior to market release.
6. Leading the preparation and direct all activities for:
e. FDA inspections,
f. ISO 13485 surveillance audits
g. Corporate audits
h. 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.
7. Ensuring continued compliance with DMR
a. Timely completion of departmental MRRs.
b. Updating related FMEAs as required.
c. Issuing and completing RCAs for correction and prevention of any related critical concerns or recurring issues.
8. Provide quality engineering support for ;
a. Technical queries relating to regulatory requests/compliance
b. Plant management review and PMR/KPI system
c. Plant MRRs and RCAs
d. Supplier issues
9. Develop and maintain a program ensuring only correctly validated equipment is used in production process. This will include:
a. Participation in validation protocol development
b. Overseeing completion of validation or validation samples
c. Supporting the manufacturing engineering function to ensure compliance to related element of quality system.
10. Monitor production process for compliance to implemented process controls to
a. ensure quality product is shipped to customer and provide:
b. Trend analysis of data from the controls
c. Potential improvements for review with engineering based on the trends.
d. Areas for Improvement to senior management.
e. Review and propose changes to sampling plans based on trend analysis and changes to the system
11. Maintain and develop vendor quality management program consisting of
a. Development and establishment of new vendors
b. Dealing with all vendor non-compliances
c. 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 information for customer distribution.
14. Maintain and develop the calibration, microbiological, sterilisation and environmental monitoring system
15. Liaise with Engineering dept. on new product development projects to ensure
a. All quality control requirements are clearly understood
b. Relevant process controls are documented and transferred to production and suitably implemented with necessary training.
16. Monitor all of above and provide reports on all of the above for senior management
17. Ensuring their direct reports play the required role in the plant annual objectives.
18. Responsible for the organisation, training and direct supervision of the relevant Quality engineers and indirectly for quality inspectors.
19. Ensure the company behavioural standards are adhered to, setting the example yourself for your direct reports.
20. Ensure all employees are briefed on a monthly basis.
21. 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.
22. Prepare and control annual budgets for your department.
23. Work efficiently using own initiative, escalating decisions to the Quality Director as, when, and only when, necessary.
24. 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.
Quality & Regulatory Manager Job Requirements
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.
- Working knowledge of Excel and Word.
- Comprehension of engineering principles adequate to allow competent participation in New product development and customer complaints.
Skilled in multitasking and prioritizing.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS: · Engineering or science Degree preferably with Quality Engineering included.
· Qualified systems lead auditor for ISO 13485 and MDD compliance.
· Experience;
o Several years experience in the Medical Device industry including a minimum of three years experience in design assurance/quality/regulatory function.
o Experience with USA regulatory requirements would be advantageous.
PHYSICAL & MENTAL DEMANDS. · Work effectively with close tolerances.
· Ability to co-ordinate, plan and organise based on priorities.
· Ability to maintain a high
level of organisation.
Quality & Regulatory Manager Application Information
Please apply with your CV and cover letter by the 'apply' button below
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Quality & Regulatory Manager Summary
| Education Backgrounds: |
Business Engineering
Healthcare Science
|
| Specialties: |
Compliance & security
HSE(Q) Management
Management
Process Management
Quality Engineering
|
| Education Level: |
Postgraduate (Masters)
Doctorate (PH.D)
|
| Experience: |
10 - 15 years
2 - 5 years
5 - 10 Years
|
| Languages spoken: |
English
|
| Job Location: |
Galway, Ireland |
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