Quality System Specialist
hace 4 semanas
About Straumann Group
The Straumann Group (SIX: STMN) is a global leader in tooth replacement and orthodontic solutions that restore smiles and confidence. It unites global and international brands that stand for excellence, innovation and quality in replacement, corrective and digital dentistry, including Anthogyr, ClearCorrect, Medentika, Neodent, NUVO, Straumann and other fully/partly owned companies and partners. In collaboration with leading clinics, institutes and universities, the Group researches, develops, manufactures and supplies dental implants, instruments, CADCAM prosthetics, orthodontic aligners, biomaterials and digital solutions for use in tooth correction, replacement and restoration or to prevent tooth loss.
Headquartered in Basel, Switzerland, the Group currently employs more than 11'000 people worldwide. Its products, solutions and services are available in more than 100 countries.
The Straumann Group unites global reach, experience and innovation with passion and a commitment for uncompromising quality, making enhanced dental healthcare available and accessible to customers and patients around the globe. The group unites global and international brands that stand for excellence, innovation, and quality, including Straumann, Neodent, Anthogyr, Medentika, ClearCorrect, Dental Wings and other fully- or partly owned companies and partners.
In 2017 Straumann entered the highly attractive market for Clear Aligner to support its strategy as becoming the leading provider for esthetic dentistry solutions. To achieve this step, the Straumann Group acquired the US-based company ClearCorrect. With determination, ClearCorrect grew into a viable player in the clear aligner space, which attracted the attention of many customers globally since 2006. Acquiring ClearCorrect has provided Straumann with technology and expertise in orthodontics.
People and culture are the Straumann Group's greatest assets; they are the keys to high performance and sustainable success. We strive for a culture that builds trust and collaboration, fosters diversity, embraces change, promotes agility, learning and innovation, creates opportunities, allows people to make mistakes and encourages them to take both responsibility and ownership. The fundamental driver of our culture is the player-learner mindset, which we seek to inspire and nurture in every employee.
Summary of Position:
Maintains ClearCorrect's Quality Management System by ensuring company procedures comply with regulatory and ISO requirements. Responsible for the administration of quality policies and procedures.
Essential Functions and Duties:
- Maintains the company Quality Management System processes and procedures required to manage product, quality, and regulatory requirements.
- Stays current with industry regulations and standards including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485, MDD/ MDR and MDSAP regulations.
- Implement and manage site training program for quality system.
- Maintains the company document and records control processes.
- Maintain the company internal audit program and performs internal audits as necessary
- Maintains the company nonconformity (NC) program.
- Maintains and manages the company corrective action (CAPA) program.
- Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures and product/process deviations as required.
- Maintains approved supplier list in coordination with multidisciplinary team, performs supplier audits, and monitors contract manufacturers' data and ensure their compliance with internal operating procedures and applicable regulations.
- Assists the Quality Engineer in maintaining the company's Risk Management program.
- Collect quality data, publish quality metrics, compile management review data and assist in scheduling Quality Metrics and Management Review meetings.
- Coordinate and prepare for corporate and site audits from health authority, notified body and key customers.
- Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
- Accurately records and reports of information as required.
- Follows employee policy within the company.
- Required reporting: audit findings and remediation, CAPA reports, NCRs, training, Quality metrics.
Non-essential Functions and Duties:
- Attends Quality and other meetings as required.
- Participates in additional training relevant to this position.
- Other duties may be assigned, directed or requested.
Minimum Qualifications:
- Bachelor's degree in Life Science, quality, engineering or related discipline or an equivalent combination of education and experience.
- 2+ years quality assurance/quality system experience in medical device discipline.
- 2+ years' experience in participating in and/or leading internal audits.
- 2+ years' experience of creation of technical and quality documents, such as management review, risk management, formal procedures/ work instruction, quality metrics etc.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes, and meets deadlines in timely manner with strong organizational and follow-up skills, as well as attention to detail.
- Basic computer skills and data analysis skills.
Preferred Qualifications:
- Support/ assist other departments than quality for investigation, collecting metrics.
- Familiarity with US and International medical device regulations .
- Utilization of basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
- dvanced computer skills, including statistical/data analysis.
Key Attributes
Straumann Group has been inspired to make people's lives better, improve oral health and restore people's self-esteem and driving the company's purpose to unlock the potential of people's lives. Culture has always been the foundation of our success, guided by our beliefs: customer obsession, entrepreneurial mindset, agility & decisiveness, ownership, passion for learning, psychological safety, and driving engagement.
Additional qualities of the successful candidate include the following:
- Resourceful and Hands-on: An energetic, resourceful, agile, and hands-on executive who operates effectively with minimum direction and pursues objectives and works to deliver against goals relentlessly; able to get to the heart of issues rapidly and act decisively.
- Team Player: From a basis of strong self-awareness, excellent interpersonal skills; fosters team-first mentality and shares wins and successes; creates an open and transparent environment in which individuals can team together to drive optimal outcomes.
- Results-driven: Brings a fire in the belly and is counted on to meet or exceed commitments on time, every time; has a genuine passion for patient outcomes and quality.
- Collaborative Relationship-builder: Able to build deep relationships with key internal and external stakeholders, and work closely with/ and earn the respect and trust of other teams.
- Integrity: Possesses unquestionable integrity and is intellectually curious; is known as an honest, trustworthy, ethical, and straightforward individual, capable of presenting the unvarnished truth in an appropriate and helpful manner.
- Straumann Group prides itself on employee's embracing the player/learner mindset that embodies a high-performance culture and learning organization.
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