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.
Salary: $55,000/Annually ($24.44/Hourly). The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position.
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 and regulatory requirements
Stays current with industry regulations and standards including 21 CFR 820, 21 CFR 803, ISO 13485, MOD/ MOR and MOSAP
Implement site training program for quality system
Maintains the company document, records, and supplier control processes
Maintains the company internal audit program
Maintains the company nonconformity (NC) program
Maintains the company corrective action (CAPA) program
Maintains approved supplier list in coordination with multidisciplinary team
Assists in maintaining the company Risk Management program
Assists in scheduling yearly Management Review and in compiling management review data
Coordinate and prepare site audit 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
Reporting on audit findings and remediation, CAPA reports, NCR's, 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
Physical Attributes:
Observe and hear warning signs and signals within all areas of the company
May type on a computer, using a computer mouse and computer monitor for up to 8 hours at a time
Able to sit or stand at a desk for approximately 8 hours per day while using a computer for extended periods of time
Will be working in a fast-paced, team environment
Work Environment:
Work is performed primarily in an office environment
The employee may occasionally be exposed to dust
The noise level in the work environment is usually quiet to moderate
Direct interaction with manufacturing environment and returned products.
Will work in a fast-paced, team environment
Minimum Qualifications:
Associate’s degree in quality, engineering, technical writing, English and/or manufacturing related discipline
2+ years quality assurance (quality system) experience in medical device manufacturing field
2+ years’ experience in participating in and/or leading internal audits
2+ years’ experience of producing technical documents, such as, draft management review, KPls at defined timeline, risk management for the quality system and formal procedures/ work instruction
2+ years’ experience of basic utilization of quality tools, such as, RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts
Preferred Qualifications:
Bachelor’s degree in quality, engineering, technical writing, English and/or manufacturing related discipline
Support/ assist other departments for investigation, collecting metrics
Familiarity with US and International medical device regulations
Lean/Six sigma Manufacturing knowledge
Excellent written communication skills
Basic computer skills (Microsoft Office)
Whether you’re looking to build your career, improve your health, or brighten your SMILE, we offer generous benefits to help you achieve your goals.
• Very Competitive total compensation plans
• A 401(K) plan to help you plan for your future with an employer match
• Great health, dental and vision insurance packages to fit your needs to ensure you’re happy and healthy. Straumann contributes a healthy portion towards employees’ premium.
• Generous PTO allowance - plenty of time to recharge those batteries!
Please understand that we do not need external support by recruiting agencies and consultants to fill this vacancy. Thank you for respecting this.
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 : Round Rock (TX)
Travel Percentage: 0 - 10%
Requisition ID: 16415
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.
