Straumann Group
Position Title: Quality Systems Specialist
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 Quality Assurance (QA) Specialist is the process owner of quality processes and systems, ensuring compliance with applicable Quality System Regulations and ISO Standards. Monitoring Quality QMS system and processes, including audit program, document control, training, CAPA, record retention, nonconformity, and customer complaint investigation. The candidate collaborates with cross-functional teams to monitor operational processes to ensure compliance with applicable Quality System Regulations and ISO Standards. Job Responsibilities:
This position is responsible for, but not limited to, the following:
- Maintain the company's eQMS modules including Document Control Management, Training Management, Change Management, Nonconformity and CAPA Management.
- Maintain Quality Management System (QMS) processes and procedures, and records required to manage product and regulatory requirements.
- Lead the company training program, nonconformity (NCR); SCAR (Supplier Corrective Action Request) programs.
- Reviews quality trends based on collected quantitative data and interactions with quality inspectors and operations personnel.
- Acquires skills and experience necessary to perform Quality Assurance tasks without supervision.
- Collaborates with the process owners and Subject Matter Experts to generate new documents or update documents to comply with industry regulations and corporate requirements.
- Assist quality improvement projects by participating and supporting project teams, resources, stakeholder relationships, timelines, and milestones.
- Execute incoming inspection and raw materials release.
- Manages and maintains supplier performance in coordination with a multidisciplinary team.
- Monitor and support the multidisciplinary team to implement the CAPA program.
- Conduct customer complaint investigations, implement correction or corrective action as required.
- Coordinate and prepare site audit from health authority, notified body and key customers.
- Accurately records and reports information as required.
- Support change control, technical transfer, or new product introduction in coordination with the multidisciplinary team.
- Assists in maintaining the company's Risk Management programs.
- Assist in product and process validation as required.
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:
The requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee:
- Will type on a computer keyboard, using a computer mouse and computer monitor for up to 8 hours at a time.
- Must be able to observe and hear warning signs and signals within all areas of the company.
Minimum Qualifications:
- Bachelor’s degree in quality, engineering and/or manufacturing fields
- 3+ years quality assurance (quality system) experience in the medical device manufacturing or related field
- 3+ years maintaining electronic QMS systems
- 3+ years of experience producing technical documents, control procedures, work instructions, and KPI
- 3+ years of experience utilizing basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
- 2+ years of experience with US and International medical device regulations, GDP/GMP requirements
Preferred Qualifications:
- Ability to support/assist other departments than quality for investigation, collecting metrics.
- Excellent listening skills.
- Excellent analytical and problem-solving skills.
- Ability to learn production sequences and the company's quality standards.
- Excellent written and verbal communication skills.
- Proficient in Microsoft Office Suite or similar software
- Six Sigma/Lean Manufacturing skills
- Lead Auditor
Additional Information:
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 (some positions include discretionary bonus, or Performance Share Units).
- 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 : Mansfield (TX)
Travel Percentage: 0%
Requisition ID: 18310
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.
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Equal employment opportunity, including veterans and individuals with disabilities.
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