Find Lead auditor, quality compliance Jobs in Clara, Oy

Lead Auditor, Quality Compliance
Integra LifeSciences —Tullamore, County Offaly
- Full-time
- Engineering
- Master's degree
- Supervising experience
Social Care Lead
Peppard Investments Ltd —Tullamore, County Offaly
- Full-time
- Bachelor's degree
- First Aid Certification
- Leadership
Quick apply
Regulatory Affairs Specialist
Teleflex —Athlone, County Westmeath
- Engineering
- Project management
- No degree
Team Lead
Inclusive Living —Athlone, County Westmeath
- €40,351 a year
- Full-time
- Nursing
- No degree
- Leadership
- Annual leave
- Employee assistance program
Quick apply
Assoc Research Scientist (Technical Lead), Cell & Molecular Biology - Athlone, Ireland
Thermo Fisher Scientific —Athlone, County Westmeath
- Full-time
- Project management
- Bachelor's degree
- No degree
Person in Charge (Social Care Leader)
Orchard Care Group —Moate, County Westmeath
- On call
- Management
- Annual leave
- Employee assistance program
Quick apply
2d
Associate Director, Quality Control - Athlone
Biogen —Athlone, County Westmeath
- Full-time
- Project management
- Bachelor's degree
- Quality control
10d
Quality Engineer
Steris —Tullamore, County Offaly
- Full-time
- Microsoft Powerpoint
- Microsoft Excel
- Bachelor's degree
Health and Safety Manager
Almac Group —Athlone, County Westmeath
- From €55,000 a year
- Full-time
- Manufacturing
- Communication skills
2d
Health and Safety Manager
Arran Chemical Company —Athlone, County Westmeath
- From €55,000 a year
- Full-time
- Manufacturing
- Communication skills
Maintenance Manager, Drug Substance
AstraZeneca —Athlone, County Westmeath
- Bachelor's degree
- AI
- Leadership
4d
Supervisor (People Manager), Biopharma - Athlone, Ireland
Thermo Fisher Scientific —Athlone, County Westmeath
- 8 hour shift
- Presentation skills
- Bachelor's degree
- No degree
2d
Global Labeling Systems Lead
Teleflex —Athlone, County Westmeath
- System design
- Supervising experience
- Bachelor's degree
Electrical Supervisors
Dornan —Athlone, County Westmeath
- Construction
- Communication skills
Senior Manager, Plant Quality Assurance
Biogen —Athlone, County Westmeath
- Full-time
- Bachelor's degree
- Continuous improvement
- Manufacturing
2d
Research & Development Engineer
Teleflex —Athlone, County Westmeath
- Microsoft Office
- Analysis skills
- Bachelor's degree
Supplier Support Administrator
AXA —Athlone, County Westmeath
- Microsoft Powerpoint
- Microsoft Excel
- Analysis skills
Research Scientist, Biopharma (Core Shift)
Thermo Fisher Scientific —Athlone, County Westmeath
- Full-time
- Research
- Project management
- Presentation skills
8d
Senior Group Leader - Cell Lab
Thermo Fisher Scientific —Athlone, County Westmeath
- Full-time
- Management
- Presentation skills
- No degree
7d
Associate Research Scientist, Biopharma
Thermo Fisher Scientific —Athlone, County Westmeath
- Full-time
- Research
- Project management
- No degree

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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 clara, oy

Lead Auditor, Quality Compliance

Social Care Lead

Regulatory Affairs Specialist

Team Lead

Assoc Research Scientist (Technical Lead), Cell & Molecular Biology - Athlone, Ireland

Person in Charge (Social Care Leader)

Associate Director, Quality Control - Athlone

Quality Engineer

Health and Safety Manager

Health and Safety Manager

Maintenance Manager, Drug Substance

Supervisor (People Manager), Biopharma - Athlone, Ireland

Global Labeling Systems Lead

Electrical Supervisors

Senior Manager, Plant Quality Assurance

Research & Development Engineer

Supplier Support Administrator

Research Scientist, Biopharma (Core Shift)

Senior Group Leader - Cell Lab

Associate Research Scientist, Biopharma

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