Sr. Quality System SpecialistS at Straumann Group in Fremont, California

Job Description:

Straumann Group


Position Title: Sr. Quality System SpecialistS

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: $90,000.00 - $105,000/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:

Maintains Bay Material’s Quality Management System by ensuring company procedures comply with regulatory and ISO requirements. Responsible for the administration of quality policies and procedures.

Essential Functions and Duties:

• Participate in the development and improvement of the company’s Quality Management System processes and procedures to effectively manage product and regulatory requirements.
• Stay informed about current industry regulations and standards, including but not limited to 21 CFR 820, 21 CFR 803, ISO 13485, MDD/MDR, and MDSAP.
• Implement and maintain the site’s quality system training program.
• Manage and oversee the company’s document and records control processes.
• Lead the company’s internal audit program, including overseeing subsequent actions and follow-ups.
• Administer the company’s nonconformity (NC) program and facilitate the multi-disciplinary Material Review Board.
• Provide oversight and guidance for the company’s corrective action (CAPA) program.
• Coordinate with multidisciplinary teams to manage and maintain the approved supplier list.
• Support the maintenance of the company’s Risk Management program.
• Assist in scheduling and preparing Management Reviews, as well as compiling and presenting review data.
• Coordinate and prepare for site audits conducted by health authorities, notified bodies, and key customers.
• Adhere to and promote safety protocols, ensuring a clean and safe work environment for oneself and others.
• Play a strategic role in documentation by developing reporting standards and analyzing data to identify trends in quality metrics.
• Lead quality initiatives within quality-focused projects and collaborate with other departments to meet all regulatory and organizational requirements.
• Accurately document and report required information in a timely and organized manner.

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 Quality, Engineering and/or Manufacturing fields
• 4+ years quality assurance (quality system) experience in medical device manufacturing field
• 4+ years' experience producing technical documents, such as draft management review, KPIs at defined timeline, risk management for the quality system and formal procedures and/or work instruction

Preferred Qualifications:

• Strong work ethic, self-motivation and problem solving skills
• Ability to work independently and in cross-functional teams with strong customer focus
• Strong attention to detail and reliability in tasks requiring high accuracy
• 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
• Support and assist other departments for investigations and collecting metrics
• Six Sigma/Lean Manufacturing skills
• Lead Auditor experience
• Proven ability to document procedures in an ISO certified environment
• Demonstrated ability to drive continuous process improvement
• Ability to analyze problems and opportunities and systematically approach them to make improvements both short term and long term
• Ability to prioritize and execute the plan to meet deadlines
• Strong analytical, organizational and critical thinking skills

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 : Fremont (CA)

Travel Percentage: 0 - 10%

Requisition ID: 16377

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.

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

PI257128941

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