Integer Manager, QA & RA in Galway, Ireland
At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
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 ;
implemented process controls,
assuring product quality,
qualification and validation
quality direction for MRRs, 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
Design Assurance through:
Development and maintaining product test methods.
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 ;
Plant change control
Customer notifications & sharing of technical information
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 Regulatory Correspondent (Canada) 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.
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.
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
Health Canada Medical Device Regulations
ISO13485 Medical Device Quality Management System
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;
Management Review & PMR/KPI system.
Audit system (Internal Audit, Customer audits, Regulatory Audits, Corporate audits)
Documentation Control system
Regular audits of the scanned DMR
Ensuring timely and accurate processing of ECOs and rework requests
Providing administrative support to Quality Dept.
Ensuring upkeep of Archives
Control master labels
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:
CE Mark 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:
ISO 13485 surveillance 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 MRRs.
Updating related FMEAs as required.
Issuing and completing RCAs for correction 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 PMR/KPI system
Plant MRRs and RCAs
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 information 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 behavioural 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.
A bility to supervise,co-ordinate, plan and organise
Rigorous attention to detail and organisation skills.
Ability to work to deadlines a nd 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.
Several years experience in the Medical Device industry including a minimum of three years experience in design assurance/quality/regulatory function.
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. REPORTING RELATIONSHIP AND PRESENCE OF SUPERVISOR.
This position reports directly to the Senior Quality & Regulatory Manager
Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at https://integer.net .
Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at