Description
Straumann GroupPosition Title: Quality Engineer
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:
Provide support to Quality and Manufacturing in areas of quality assurance. Actively participate in technology transfer, continuous improvement, manufacturing support, leading project teams, quality planning, customer complaint, and Corrective and Preventive Actions (CAPA) and other duties as assigned by the Sr. Quality Manager.
Essential Functions and Duties:
This position is responsible for, but not limited to, the following:
- Support new product introduction and technology transfer of processes / articles by providing complete, accurate, and efficient quality plans; this includes sampling points and plans, process control requirements, test methods, measurement technique and evaluation criteria throughout the manufacturing process
- Perform product and process evaluations to identify areas for improvement. Recommend solutions to identified problems; Implement approved changes using sound quality engineering principles and fully document them in compliance with applicable regulatory standards
- Support manufacturing by analyzing defect conditions as necessary to implement corrective actions and perform day-to-day troubleshooting and resolve immediate problems on the manufacturing floor
- Lead cross functional projects as assigned
- Perform process capability studies, design experiments, risk analysis, gage repeatability and reproducibility studies, statistical evaluations as necessary to increase control and lower total quality costs
- Lead qualification / validation efforts as defined in Validation Master Plan; provide complete, accurate, and well-organized documentation for requirements, plans, reports, PFMEA's, checklists, etc. as determined by validation teams
- Act as Quality representative for NCR, CAPA's, etc.as required
- Support GDM Doc Control, SAP Doc Control, and SAP Material Set Up
- Act as Process owner of Change Control Process
- Manage Calibration and Preventative Maintenance program
- Conduct internal and supplier audits if required
Non-essential Functions and Duties:
- Other duties as may be assigned
- Participate in meeting departmental goals and objectives
- Maintain job related processes / work instructions
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: From a basis of strong self-awareness, excellent interpersonal skills; fosters team- first mentality and shares wins and successes; creates an open and transparent environment in which individuals can team together to drive optimal outcomes
- Results-driven: Brings a fire in the belly and is counted on to meet or exceed commitments on time, every time; has a genuine passion for patient outcomes and quality
- Collaborative Relationship-builder: Able to build deep relationships with key internal and external stakeholders, and work closely with/ and earn the respect and trust of 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
Physical Attributes:
- Type on a computer keyboard, using a computer mouse and computer monitor for up to 8 hours at a time
- Observe and hear warning signs and signals within all areas of the company
Work Environment:
- Work is performed in a manufacturing environment
- The employee is expected to operate machinery with moving parts
- The employee may occasionally be exposed to dust
- The noise level in the work environment is consistently moderate
- The employee will be working in a fast-paced, team environment
Minimum Qualifications:
- Bachelor's degree in engineering or related field
- 5+ years of experience as an engineer in a related field
- 1+ years of experience in sampling, statistical analysis, failure investigation, troubleshooting, validation, process capability, DOE, GR&R, quality assurance, and quality systems in a medical device environment
- Familiarity with US and International medical device regulations
- Experience with GMP, FDA and ISO standards
- Word, Excel, Project, statistical software computer skills
Preferred Qualifications:
- Ability Support / assist other departments than quality for investigation, collecting metrics
- Six Sigma/Lean Manufacturing skills
- Strong verbal and written communication skills
- Analytical problem-solving skills
- Interpersonal skills
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.
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: 19405
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.
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
.
PI279522791