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As a global leader in mass spectrometry, SCIEX delivers solutions for precision detection and quantification of molecules to help protect and advance the wellness and safety of all. Because of our 50 years of groundbreaking innovation, our customers can quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster, and keep food healthier and safer. At SCIEX, you’ll find a rewarding role that amplifies your impact on the world and helps you realize life’s potential.

SCIEX is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Purpose of this role:

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Maintain and comply with the requirements of ISO9001, ISO13485, FDA 21 CFR Part 820 and other applicable regulatory requirements.

• Participate and lead cross-functional teams working on key company initiatives.

• Track, report, & improve key quality indicators for compliance and efficiency.

• Identify, report, and seek correction for deviations noted in workplace. Embrace a behavior of employee involvement and commitment to doing the job right the first time.

Doc Control & Training

• Author, review and/or approve documentation as required

• Support the development and administration of Doc Control and Training via the electronic document management system.

• Establish and provide QMS related training based on schedule (e.g. New Hire Induction, QMS refresher, Doc Control, etc.)

• Pro-actively improve quality systems to support manufacturing including reviews across all areas of operations to ensure a level of consistency and standardization in QMS.

• Ensure that all document changes generated (via Change Requests ) are compliant to internal procedures and are being reviewed and approved by all appropriate functions.

• Improve existing work instructions and procedures related to doc control & training

• Maintain in-process and store and control archived documentation and records in accordance with established company procedures

• Provides formal guidance to other team members related to doc control and training processes

• Foster/promote a quality culture through involvement in ongoing education, consultation in the Quality/Regulatory requirements on an ongoing basis.

• Conduct training to stakeholders in the event if there is a change in the standard process or introduction of new process.

Auditing:

• Act as lead quality auditor for quality audits, including development of audit plans, managing audit teams.

• Lead or provide technical support to a variety of audit needs (e.g., compliance, supplier, audit readiness).

• Support audit activities including pre-audit planning, audit readiness and post-audit follow-up with external auditor.

• Mentor and coach individuals and teams while resolving problems and implementing best practices.

• Drive closure of NCMRs, Issues, CAPAs and Audit action items related to QMS and compliance issues. Work with cross functional department to ensure that issues are addressed & closed in a timely manner.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in engineering or equivalent.

• A minimum of 2 years of related experience in a manufacturing environment especially instruments manufacturing.

• Good understanding of the following QMS standards - ISO9001 QMS, ISO13485 QMS and FDA 21 CFR Part 820

• Experience in conducting/leading QMS audits.

• Experience in handling document control management program (EDMS), record management

• Experience in writing procedures to QMS requirements.

  When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

  Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.