Find Lead auditor, quality compliance Jobs in Ferbane, Oy

Lead Auditor, Quality Compliance
Integra LifeSciences —Tullamore, County Offaly
- Full-time
- Engineering
- Master's degree
- Supervising experience
Team Lead
Inclusive Living —Athlone, County Westmeath
- €40,351 a year
- Full-time
- Nursing
- No degree
- Leadership
- Annual leave
- Employee assistance program
Quick apply
Project / Graduate Engineer
Pat Loftus Construction Ltd. —Tullamore, County Offaly
- €45,000–€55,000 a year
- Full-time
- Bachelor's degree
Quick apply
12d
Home Care Supervisor
Care About You (Midlands) —Athlone, County Westmeath
- 8 hour shift
- Customer service
- No degree
- Data entry
- Employee assistance program
- Employee discount
Quick apply
2d
Senior Site Manager
NFT Logistics —Athlone, County Westmeath
- €54,117.19–€106,623.11 a year
- Full-time
- Supervising experience
- No degree
- IT
Quick apply
6d
Lead Operator (m/f/x)*
Solventum —Athlone, County Westmeath
- Full-time
- Microsoft Excel
- Oracle
- ERP systems
Director, Quality Management Systems
Teleflex —Athlone, County Westmeath
- Engineering
- Project management
- Bachelor's degree
13d
Sr. Director, Strategic Regulatory Affairs and UDI
Teleflex —Athlone, County Westmeath
- Engineering
- Microsoft Office
- Analysis skills
14d
Quality Engineer
Steris —Tullamore, County Offaly
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Bachelor's degree
Supervisor (People Manager), Biopharma - Athlone, Ireland
Thermo Fisher Scientific —Athlone, County Westmeath
- 8 hour shift
- Presentation skills
- Bachelor's degree
- No degree
Global Labeling Systems Lead
Teleflex —Athlone, County Westmeath
- System design
- Supervising experience
- Bachelor's degree
Scientist III (Pharma)
Thermo Fisher Scientific —Athlone, County Westmeath
- Full-time
- Analysis skills
- Bachelor's degree
- No degree
Level 1 (Graduate) Consultant
Malone O'Regan Environmental —Tullamore, County Offaly
- Full-time
- Microsoft Office
- Bachelor's degree
- Organisational skills
Quick apply
2d
Electrical Supervisors
Dornan —Athlone, County Westmeath
- Continuous improvement
- Communication skills
Associate Research Scientist, Biopharma
Thermo Fisher Scientific —Athlone, County Westmeath
- Full-time
- Research
- Project management
- No degree
Senior Group Leader - Cell Lab
Thermo Fisher Scientific —Athlone, County Westmeath
- Full-time
- Management
- Presentation skills
- No degree
HR Administrator
Nelipak Healthcare Packaging —Clara, County Offaly
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Office
- Wellness program
- Flexitime
Quick apply
7d
Accounting Specialist
Reynolds Commercials —Athlone, County Westmeath
- €55,000–€70,000 a year
- Full-time
- Accounting
- Flexitime
- Employee assistance program
Quick apply
3d
Manufacturing Lead Operator - Shift work
Spectrum Plastics Group —Tullamore, County Offaly
- Full-time
- Quality control
- Business
- Communication skills
Quick apply
7d
Procurement Specialist
Integra LifeSciences —Tullamore, County Offaly
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
14d

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Lead Auditor, Quality Compliance

Integra LifeSciences -
Tullamore, County Offaly

Apply Now

Job details

Full-time

Qualifications

Engineering
Google Cloud Platform
Master's degree
Supervising experience
Bachelor's degree
Manufacturing
Leadership

Full job description

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The Lead Auditor, Quality Compliance will form part of the Corporate Audit team and will lead, coordinate and perform corporate audits of the Quality Management System (QMS) as part of Integra LifeScience’s quality internal audit program across more than 15 design, manufacturing, and distribution facilities and a diverse portfolio of leading medical devices.

RESPONSIBILITIES

Obtain satisfaction through evidence-based investigation techniques that the global QMS policies and standards, the global policies and procedures and the regulatory and legislator requirements are being complied with consistently and to the required level.
Supply, in an agreed written format, a formal report to the head of the audit program on the conduct of each site audit, describing the way the audit was conducted, the context and a categorized list of audit observations and recommendations made during the audit, an overall site classification for the site and an executive summary designed to be communicated to the heads of Global Quality, Supply Chain, Regulatory Affairs, Product Development, and business leaders as required or applicable.
Identify problematic areas of site and quality system operations during the audit and assist the site representatives during, and following, the audit with assistance, suggestions and recommendations for the site to reach the desired level of improvement.
Support site inspection readiness through formal corporate audits as well as informal high-risk CAPA reviews, mock inspection role-playing and SME / auditee coaching and feedback.
Work with the head of the audit program to identify areas of improvement in terms of efficiency and efficacy of the corporate audit processes and systems whilst retaining the same levels of quality control.
Facilitate Global implementation of policies at the divisional, site and third-party representative level by clear and consistent application of a mix of auditing, education, communication and enforcement that quickly escalate or drive down potential issues within the organization.
Lead or physically participate in, the required number of corporate audits and work with Site Quality Representatives to quickly finalize the reports within the standard timelines.
Recommend to the head of the audit program any additional work required with the audited sites such as follow-up or re-audits and participate in any continuous improvement or quality initiatives as a representative of Global quality organization.
Provide review and support to individuals, working groups or sites within the company or approved suppliers outside the company on the specific technical area of expertise.
Continues to develop and expand own personal skills, specific professional and technical expertise and technical auditing knowledge as far as personal ambition and ability will support it, whilst staying within the general scope of this job description.
Support a quality culture of continuous improvements and foster collaboration with cross-functional groups and sites.
Demonstrates technical expertise and leadership as an inter-departmental resource coaching and teaching other Integra team members across all functions and geographies.
Perform other related duties as expected.

QUALIFICATIONS

Experience with Corporate, divisional, site, supplier GMP, GDP, GLP or GCP (as applicable) audits as a Lead Auditor for multi-national manufacturing companies in the medical devices or pharmaceutical sector.
Related quality/operations GMP work experience in a medical device or pharmaceutical manufacturing site or an equivalent combination of education and work experience in QS/QA/QC/OPS or a technical management and supervisory function.
Experience auditing technical files for conformance with EU regulations for CE-marked medical devices.
Experience working for regulatory agencies (such as U.S. FDA, MHRA, TGA, Health Canada, SFDA, ANVISA, US state, etc.) or Notified Bodies (such as BSI, NSAI, LRQA, TüV, etc.) preferred.
Experience in one or more of these specialized technical areas: sterilization, microbiology, manufacturing facility engineering and design, statistical analysis, process validation, regulatory compliance, clinical trials, computer systems validation, quality systems and/or data security.
A working knowledge of different languages and a willingness to travel widely, including internationally, (up to 50%) would also be considered as assets.
Conducting supplier / regulatory compliance audits at medical device and/or pharmaceutical companies with a demonstrated ability to identify and resolve complex quality and compliance issues.
Intimate knowledge of the 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, and MDSAP country requirements; personal experience in the roll-out and implementation of GMP, GDP, GCP, GLP, and ISO 14971 would be considered an asset.
Participated in or personally led audits of materials suppliers, manufacturing sites, distribution centers, and/or laboratories as a Lead Auditor or site QA/RA representative.
Bachelor’s degree in engineering, or sciences or relevant technical field required. Master’s degree preferred.
Formal Auditor certification by a recognized body (e.g., IRCA, ASQ CQA, BSI, Exemplar Global).
Minimum 15 years of experience in auditing in quality, manufacturing, or engineering, or equivalent education and years of experience.
Experience in FDA controlled environment.
Strong collaboration skills and experience working in a matrix environment.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Apply Now

Refine Your Search

lead auditor, quality compliance jobs in ferbane, oy

Lead Auditor, Quality Compliance

Team Lead

Project / Graduate Engineer

Home Care Supervisor

Senior Site Manager

Lead Operator (m/f/x)*

Director, Quality Management Systems

Sr. Director, Strategic Regulatory Affairs and UDI

Quality Engineer

Supervisor (People Manager), Biopharma - Athlone, Ireland

Global Labeling Systems Lead

Scientist III (Pharma)

Level 1 (Graduate) Consultant

Electrical Supervisors

Associate Research Scientist, Biopharma

Senior Group Leader - Cell Lab

HR Administrator

Accounting Specialist

Manufacturing Lead Operator - Shift work

Procurement Specialist

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