Job Description:
Straumann GroupPosition Title: Sr. Quality Engineer
Location/s: Fremont (CA), United States
Job Category: Quality Assurance
Company: BMUS - Bay Materials 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: $90,800.00 - 105,000.00$/Annually. 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:
This position is onsite in Fremont, CA. The Sr Quality Engineer maintains Bay Material’s Quality activities related to operations, quality controls activities, supplier quality management and participating to investigation ensuring company procedures, regulatory and ISO requirements.
Essential Functions and Duties:
- Manage non-conformances, including conducting root cause analysis, implementing corrective and preventive actions (CAPA), and ensuring proper resolution and documentation.
- Lead continuous improvement initiatives by automating measurement techniques, simplifying SPC requirements, clarifying work instructions, and evaluating processes for efficiency.
- Support validation and qualification efforts internally and with suppliers as defined in the Validation Master Plan, including equipment qualification, process validation, PFMEAs, and risk assessments, while maintaining comprehensive documentation.
- Facilitate technology transfer activities with suppliers by developing quality plans, sampling plans, process controls, and test methods to ensure smooth production transitions with accurate documentation.
- Perform statistical analyses such as process capability studies, GRR (Gage Repeatability and Reproducibility), DOE (Design of Experiments), and risk analysis to control processes and reduce quality costs.
- Participate in and support Design and Process FMEA (Failure Modes and Effects Analysis) activities, including updating risk management files and implementing mitigation strategies.
- Provide manufacturing support by troubleshooting production issues, analyzing defects, developing inspection methods, and overseeing calibration, verification, and maintenance of measuring equipment.
- Collaborate with QC Inspectors to select and manage appropriate metrology equipment for production needs.
- Manage document control processes, including the creation and maintenance of engineering change orders (ECOs), work instructions, and other quality system documentation to ensure compliance with QSR and ISO standards.
- Maintain ongoing compliance through process optimization, re-validation activities, and accurate record-keeping in alignment with internal policies and industry regulations.
- Lead and participate in cross-functional teams, validation projects, and quality reviews to meet organizational goals and drive quality initiatives.
- Manage and improve key quality metrics, support CAPA processes for production-related issues, and identify opportunities for process optimization.
- Contribute to departmental goals and objectives by collaborating with internal and external stakeholders to achieve continuous improvement.
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:
- 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
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
- The employee must be able to work in a fast-paced team environment
Minimum Qualifications:
- Bachelor’s degree in engineering, material science, chemistry, and/or manufacturing
- 5+ years quality engineering experience in certified quality engineering, quality assurance, or a related role in a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology, or manufacturing).
- 5+ years' experience producing technical documents, such as quality plans, KPls at defined timeline, risk management in NCR and PFMEA for the quality system and formal procedures and/or work instruction
- 5+ years’ experience with ISO standards (e.g., ISO 9001, ISO 13485) and FDA regulatory guidelines (e.g., 21 CFR Part 820, 21 CFR Part 211)
Preferred Qualifications:
- Master’s degree in engineering, material science, chemistry, and/or manufacturing
- Experience in leading supplier audits, nonconformance investigations, and corrective/preventive actions (CAPA)
- Strong work ethic, self-motivation and problem-solving skills
- Ability to work independently and in cross-functional teams with strong customer focus
- Ability to utilize Microsoft Office (Access, Excel, Word, PowerPoint) particularly Excel where advanced skills are a plus (Excellent Microsoft Excel skills are required)
- Familiarity with US and International medical device regulations
- Ability to utilize the basic quality tools including RCA, Fishbone analysis, SPCs, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts
- Statistical analysis such as SPC and data monitoring skills
- Support and assist other departments for investigations and collecting metrics
- Six Sigma/Lean Manufacturing skills
- APQP / PFMEA / Control plans experience
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.
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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 : Fremont (CA) || United States : San Francisco (CA)
Travel Percentage: 0 - 10%
Requisition ID: 16411
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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