Quality Engineer at Straumann Group in Round Rock, Texas

Job Description:

Straumann Group


Position Title: Quality Engineer

Location/s: Round Rock (TX), 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 $78,800-$98,500. 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

Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development of and enforces internal systems and procedures to meet ISO standards, FDA quality system regulations, and other regulatory requirements. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process.

Essential functions and duties

• Support 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 QSR and ISO standards

• At times, 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

• Act as Quality representative for NCMR’s, ECO’s, CAPA’s, etc.as required

• Participate in validation teams, PFMEA’s, investigations, etc. as required

• Works with cross functional teams to implement changes in accordance with internal procedures.

• Assists with training of quality and compliance concepts and best practices.

• Work with Quality team and cross-functional teams to conduct quality investigations, identify root causes, and present potential solutions.

• Support product registration and surveillance activities by generating supporting technical documentation.

• Plans and performs technical studies, including biocompatibility studies.

• Collects and analyzes quality data.

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

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. A reasonable accommodation may be made to ensure individuals with disabilities are able to perform the essential functions of the role.

• Bachelor’s degree in quality, engineering and/or manufacturing fields required

• Must have 3+ years quality engineering experience in medical device manufacturing field with focus on design and production

• Ability to work with multidisciplinary teams to execute projects, investigations, and training

• Demonstrated ability to plan and work to robust timelines

• Experience in planning, execution and reporting of equipment and process validations

• Excellent understanding of quality principles and good documentation practices

• Familiarity with US and International medical device regulations

• Must be familiar with and competent in conducting and managing Risk Management plans and summaries

• Familiarity with ISO 14971 and 10993 preferred

• Knowledge of design control processes

• Experience in investigation technics and problem solving

• Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts

• Must be able to produce technical documents, testing and validation plans, IQ/OQ/PQ protocols and formal procedures

• Six Sigma/Lean Manufacturing skills recommended

• Must have excellent written communication skills

• Must have basic computer skills including Microsoft Office

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:

• 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 requirements:

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.

Language skills

Ability to read and interpret training documents, safety rules, operating manuals, maintenance instructions and procedural documents.
Required reporting

This position is responsible for reporting of the following metrics on a regular basis:

• Validation planning and results

• Change requests (design and manufacturing changes)

• Risk management mitigators

• Other quality metrics as assigned

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!

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: 17276

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




Equal employment opportunity, including veterans and individuals with disabilities.

PI266245587

Salary:

$78,800.00

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