ZEISS

optics and optoelectronics

QMSManager

Lisboa, Portugal FULL TIME
The Brief

“QMS Manager at ZEISS. Skills: QMS, Audits, CAPA, Stakeholder management. Support QMS maintenance and improvement. Identify process gaps and support risk assessments”

What You'll Achieve.

ensure compliance with standards; ensure timely follow-up and closure of audit actions; enhance QMS processes

Industry & Context.

optics and optoelectronics
Problems you'll solve

data analytical and problem-solving skills; Identify process gaps; support risk assessments; implementation of corrective and preventive actions (CAPA); Analyze audit outcomes, deviations, and quality metrics to identify improvement opportunities

Eligibility Requirements

Willingness to travel occasionally, Ability to work across different time zones and functions

What They're Looking For.

Must Have

Bachelor’s or Master’s degree in engineering, natural sciences, or related field, Knowledge of MDSAP, ISO 13485 and ISO 9001 standards, GxP requirements, 3–5 years of experience in Quality Management in a regulated industry (medical devices, pharmaceuticals, or similar), Experience with QMS processes and audits, 3-5 years proactive collaboration in digital quality systems, Understanding of QMS processes and regulatory requirements, Basic knowledge of audit methodologies and CAPA processes, data analytical and problem-solving skills, Good communication and stakeholder management skills, Ability to work in cross-functional and international environments

Nice to Have

Lead Auditor certification is a plus, 3-5 years Computer System Validation experience is an advantage, Fluent in German is a plus

What You'll Do.

Support QMS maintenance and improvement

Identify process gaps and support risk assessments

and execution of audits

Prepare QMS performance data and reports

and maintenance of digital RA/QMS tools

Analyze audit outcomes

Support training activities related to QMS processes

Provide guidance to stakeholders on QMS requirements

How You'll Work.

Team & Collaboration

cross-functional coordination; stakeholder management; Ability to work in cross-functional and international environments; Support cross-functional initiatives; Provide guidance to stakeholders

Communication Scope

Good communication and stakeholder management skills

Process & Methodology

Coordination of audits, Tracking findings and closure of audit actions, Management of Change Review Board (CRB) meetings, Tracking quality-relevant changes

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