Straumann Group
Position Title: Quality Control Inspector
Location/s: Mansfield (TX), United States
Job Category: Quality Assurance
Company: EMUS - Etkon Manufacturing Inc.
Description:
#ChangeMakers
Ready to make an impact?
We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.
We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others
We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.
#WeChangeDentistry every day. Be part of it.
Position Summary:
The operator is responsible for checking all batches during incoming inspection, in process, and before delivery to outbound any non-conformities according to the product specification and control plan.?
Essential Functions and Duties:
This position is responsible for performing incoming inspection, quality control in process production, final inspection, and not limited to the following:
- Access SAP system to obtain the material and production information for incoming inspection
- Select and evaluate samples of materials, semi-finished products, or products from each batch
- Perform required inspections to ensure the material and products conform to the approved specification and control plan in SAP
- Disposition the material and product (pass/fail) according to the approved specification and control plan
- Records inspection results in SAP system
- Perform final disposition batches to distribution.
- Review and complete the final Device History Records according to Good Documentation Practices
- Handling the non-conforming material, product, as per the approved work instructions
- Participate, when necessary, in quality, production, process or development activities
- Keep the information and documents of the processes updated, controlled and archived, through electronic or physical means, when applicable.
- Provide technical advice to its internal clients on matters in its area of expertise.
- Keep up to date with the concepts, techniques, tools, methodologies and trends of the subjects related to their area of expertise.
- Analyze problems that have occurred, proposing and implementing solutions that ensure the continuity of the work.
- Support the development of various reports, aiming to support technical and managerial decision-making.
- Record the tasks performed, including time notes, in the software adopted by the company.
- Propose improvements in processes.
- Analyze proposals and develop process improvements;
- Implement procedures, methodologies, standards and policies, as well as solutions for matters related to its area of operation;
- Comply with all medical device regulation requirements, internal and general, and human resources policies of Straumann Manufacturing, Inc.
- Other duties as assigned by the management.
Quality Management
- Comply with and maintain the commitment to the Quality Policy
- Adherent to all company policies, work rules, and the Straumann Code of Conduct, including Ethics.
- Ensure the environmental conditions at the workstation are in accordance with the definitions and requirements for organization, cleaning, equipment, and operating instructions.
- Follow procedures and complete documentation
- Perform job duties in compliance with work instructions.
- Apply a disciplined approach to ensuring conformance to medical device regulations, and clean and maintain production equipment standards.
Work Environment/Physical Attributes
- Maintain a clean and safe work area.
- Comply with the Medical Devices Good Manufacturing Practices
- Ensures safety of manufacturing processes to protect employees from work-related harm (zero-accident mentality).
- The noise level in the work environment is consistently moderate
- The employee will work in a fast-paced, team-oriented environment
- Standing for long periods and occasional lifting of up to 35 lbs.
Minimum Qualifications:
- Completed High School Diploma or equivalent required.
- Minimum 3+ years of experience working in quality control processes.
- Basic understanding of the manufacturing requirements in regulated environments.
- Basic understanding of Good Documentation Practices (GDP)
- Able to interact with a computer-managed workflow.
- Proficient in computer skills, including Microsoft Outlook, Word, and Basic Excel.
Preferred Qualifications:
- Basic knowledge of SAP or ERP system
- Basic understanding of medical devices or dental implant products.
- Basic knowledge of Machining
- Knowledge of Quality Tools, including sampling plan, Measuring Instruments
- Basic knowledge of FDA regulation, ISO 13485:2016 requirement, Health Canada and MDD/MDR requirements
- Ability to work with small, high-quality parts, critical analysis, and attention to detail.
- Able to communicate and collaborate effectively.
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: Fosters team-first mentality and shares wins and successes; creates an open and transparent environment in which individuals can work together to drive optimal outcomes.
- Results-driven: Accountable to meet or exceed commitments on time, has a genuine passion for ensuring quality and patient outcomes.
- Collaborative Relationship-builder: Able to build deep relationships with key internal and external stakeholders, work respectfully with 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
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
Employment Type: Full Time
Alternative Locations: United States : Mansfield (TX)
Travel Percentage: 0%
Requisition ID: 19268
Equal Opportunity and Affirmative Action Employer (US applicants only)
Straumann Group is an equal opportunity employer and will not discriminate against any employee or applicant for employment on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national origin, age, veteran status, or disability unrelated to job requirements. Straumann Group will take affirmative action to ensure that qualified applicants are employed and that employees are treated without regard to their race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran and disability status. In compliance with U.S. Department of Labor Executive Order 11246, Section 503 of the Rehabilitation Act, and Section 4212 of the Vietnam Era Readjustment Assistance Act, Straumann Group has developed and maintains an affirmative action program and plan.
We comply with the Employee Polygraph Protection Act (EPPA), and Massachusetts law. It is unlawful for private employers to use lie detector tests for pre-employment screening or during employment, except in limited circumstances. An employer who violates this law shall be subject to criminal penalties and civil liability.
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E-Verify Participation
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Pay Transparency Nondiscrimination
Straumann Group EEO-AA Policy
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Equal employment opportunity, including veterans and individuals with disabilities.
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