By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do:
1. Customer: We focus on our customers’ success.
2. Innovation: We create better solutions.
3. Collaboration: We create success together.
4. Inclusion: We always interact with others respectfully.
5. Candor: We are open and honest with one another.
6. Integrity: We do the right things and do things right.
Job Role
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 with 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:
o Implemented process controls.
o Assuring product quality.
o Qualification and validation.
o Quality direction for NCRs, 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.
Essential Job Duties and Responsibilities
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 covering 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.
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.
Compile and prepare technical information for customer distribution.
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 four years experience in design assurance/quality/regulatory function.
* Experience with USA regulatory requirements would be advantageous.
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.
* Ability to work to deadlines and on own initiative.
U.S. Applicants: EOE/AA Disability/Veteran
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