Quality Systems Specialist at Straumann Group in Round Rock, Texas

Job Description:

Straumann Group


Position Title: Quality Systems Specialist

Location/s: Round Rock (TX), M, United States

Job Category: Quality Assurance

Company: CCUS - Clear Correct LLC

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.

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.

Videos To Watch

https://youtu.be/3lq5BLAvIdQ

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.

EEO is the Law - English Acccessible Version
EEO is the Law - English
EEO is the Law - Spanish
EEO is the Law - Supplement
E-Verify Participation
IER Right to Work
Pay Transparency Nondiscrimination
Straumann Group EEO-AA Policy

PI259068154

Apply Now