Quality System Specialist
Location
Indiana | United States
Job 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:
Support effective quality processes and systems to ensure compliance to applicable Quality System Regulations and ISO Standards. Monitor existing processes through tracking, identifying and implementing process improvements. Coordinate and support the internal and external audit programs. Maintain CAPA systems and files.
Job Responsibilities:
- Maintains the company Quality Management System (QMS) processes and procedures required to manage product and regulatory requirements
- Ensure the Quality Management System (QMS) comply with current industry regulations and standards including FDA Regulations 21 CFR 820, ISO 13485, MDD / MDR and MDSAP requirements
- Identify and deliver strategic and improvements and inputs into the QMS
- Manages the company document and records control processes
- Manages document periodic review and generate new documents or update documents to comply with industry regulations and corporate requirements
- Lead quality improvement projects by managing project teams, resources, stakeholder relationships, timelines, and milestones
- Management and implement training program
- Manages the company nonconformity (NCR); SCAR (Supplier Corrective Action Request) programs
- Assist incoming inspection and raw materials release
- Manages and maintains supplier performance in coordination with multidisciplinary team
- Act as the CAPA coordinator and manage the corrective action (CAPA) program
- Conduct customer complaint investigations, implement correction or correction action as required
- Coordinate and prepare site audit from health authority, notified body and key customers
- Manages the company supplier and internal audit program
- Accurately records and reports of information as required
- Assists in scheduling yearly Management Review and in compiling management review data
- Support change control, technical transfer, or new product introduction in coordination with multidisciplinary team
- Assists in maintaining the company 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:
- High school diploma or GED + some college
- 3+ years quality assurance (quality system) experience in medical device manufacturing field
- 3+ years familiarity with US and International medical device regulations
- 3+ years familiaritywith GDP/GMP requirements
- 3+ years of basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts
- 3+ years of producing technical documents, such as draft management review, KPIs at defined timeline, risk management for the quality system and formal procedures / work instruction
- 2+ years of experience with US and International medical device regulations
Preferred Qualifications:
- Bachelor’s degree in quality, engineering and/or manufacturing fields
- Excellent written communication skills
- Basic computer skills (Microsoft Office Suite)
- Ability to support / assist other departments than quality for investigation, collecting metrics
- 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
• 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 : Abilene (TX) || United States : Dallas (TX) || United States : Denton (TX) || United States : Fort Worth (TX) || United States : Frisco (TX) || United States : Garland (TX) || United States : Grand Prairie (TX) || United States : Irving (TX)
Travel Percentage: 0 - 10%
Requisition ID: 11468
Job tags
Salary
