Sr. Manager Medtech Quality Systems

vor 2 Wochen

Zug, Schweiz Johnson & Johnson Vollzeit

**EXPERIENCE AND EDUCATION**
- Bachelor’s degree in a technical or science-related field or equivalent
- Master degree prefered
- 8-10 years related experience
- 3-5 years QMS specific experience in a management/supervisory role
- Auditing experience
- Knowledge of 21 CFR 820, ISO 13485, Medical Device Directive (MDD) and Medical Device Regulation (EU MDR), and other applicable regulations and standards

**REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS**
- Experienced in Quality Management Systems, more specifically
- Leadership, teamwork, collaboration and influencing skills
- Demonstrated initiative and assertiveness
- Project management skills
- Written and oral communication skills
- Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Strong organizational, interpersonal and collaborative skills
- Ability to deal with pressure and provide constructive feedback. Must be able to work as part of a team as well as independently
- Capable of building internal and external partnerships with experience in stakeholder management
- Experienced internal (or external) auditor experience
- Accountability, with a strong desire to commit
- Ability to build partnerships both internally and externally
- Capacity to put the customer central to all thinking
- Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures

**Qualifications**:
**EXPERIENCE AND EDUCATION**
- Bachelor’s degree in a technical or science-related field or equivalent
- Master degree prefered
- 8-10 years related experience
- 3-5 years QMS specific experience in a management/supervisory role
- Auditing experience
- Knowledge of 21 CFR 820, ISO 13485, Medical Device Directive (MDD) and Medical Device Regulation (EU MDR), and other applicable regulations and standards

**REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS**
- Experienced in Quality Management Systems, more specifically
- Leadership, teamwork, collaboration and influencing skills
- Demonstrated initiative and assertiveness
- Project management skills
- Written and oral communication skills
- Investigative skills such as analytical problem solving, fish bone, root cause analysis, etc.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment
- Strong organizational, interpersonal and collaborative skills
- Ability to deal with pressure and provide constructive feedback. Must be able to work as part of a team as well as independently
- Capable of building internal and external partnerships with experience in stakeholder management
- Experienced internal (or external) auditor experience
- Accountability, with a strong desire to commit
- Ability to build partnerships both internally and externally
- Capacity to put the customer central to all thinking
- Ability to discern critical issues amidst broad operating unit complexity and to engage and achieve executive management support for proactive and reactive measures

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