Senior Staff QE

Stryker Corporation; Hartnett's Cross; On-site; EUR 62,000 - 105,000; Full time

Benefits offered by this job

Stryker benefits

Job summary

Stryker Corporation in Macroom, Ireland, is seeking a senior validation professional for a 23-month contract. The role is onsite and focuses on defining validation strategies and leading local teams. You will ensure regulatory compliance, review validation documentation, mentor graduates, and collaborate across Corporate and Local Validation Teams.

Ireland pay ranges from €62,000 to €105,000 per year. Travel about 10% is anticipated; you will work within Corporate Procedures and site

Qualifications

• Bachelor of Science, Engineering or related subject and 6+ years of experience in Quality/validation.

Responsibilities

• Define validation strategies per corporate procedures and regulatory requirements.
• Lead local validation teams and provide technical guidance.
• Review validation documentation to ensure compliance with regulations and best practices.
• Mentor Graduate Validation Engineers and establish industry-standard validation practices.
• Collaborate with Corporate and Local Validation Teams to approve revisions.

Skills

Quality/validation

Education

Bachelor of Science, Engineering or related subject

Job description

23 month contract with full Stryker benefits. It is a fully onsite role in our Macroom siie.

Work Flexibility

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

What you will do

• Participating in the definition of the Stryker validation strategy to be outlined in Corporate procedures and based on regulatory requirements.
• Responsible for local validation teams in terms of technical expertise and definition of best practices.
• Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at several sites.
• Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.
• Will work within the QA group, responsible for validation related activities, including, but not limited to the following:
• Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
• Participating within Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
• Being Subject Matter Expert in more than 1 validation specialty for development of Corporate Procedures and Work Instructions.
• Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
• Representing validation at both internal and external audits.
• Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
• Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
• Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
• Reviewing and approving of Validation/Qualification Documentation.
• Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.
• Mentoring for Graduate Validation Engineers.
• Establish Validation standards in terms of Industry Best Practices and drive this level across the organization.

What you will need

Bachelor of Science, Engineering or related subject and 6 plus years of experience in Quality/validation.

Ireland Pay Ranges

Ireland: €62,000 - €105,000 EUR Annual

Travel Percentage

10%

Company Overview

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com