Description
Straumann GroupPosition Title: Quality Manager
Location/s: Andover (MA), United States
Job Category: Quality Assurance
Company: STUS - Straumann US
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:
This position is responsible to provide overall quality support to the organization. To ensure the Quality Management System (QMS) is fully implemented in accordance with US Food and Drug Administration (FDA) and Health Canada requirements which includes management of Human Cells, Tissues, And Cellular and Tissue-Based Products.
Job Responsibilities:
This position is responsible for, but not limited to, the following:
• Lead the management, operation, and improvement of the Quality Management System to maintain compliance with applicable regulations
• Supervise and manage development, implementation, and maintenance of SOPs and Work Instructions engaging the cross functional team to ensure support and adherence to the QMS
• Support all internal and external quality system audits and ensure timely response to any audit concerns
• Monitor third party supplier quality and report on performance
• Perform supplier audits as assigned
• Manage the Corrective Action Preventive Action (CAPA) Process and facilitate CAPA completion
• Manage the Non-Conformance Material Report (NCMR) Process in collaboration with the corporate team
• Support in management of product recalls
• Implement and manage an internal audit program
• Administer the training system and perform Quality Training as required
• Manage the Tissue Bank registrations for applicable states and the FDA
• Report quality metrics to senior/executive management as needed of others including maintaining a clean and safe work area
• Accurately records and reports information as required
• Follows employee policies within the company
• Other duties as assigned.
Management Responsibilities:
This position manages the following positions: Quality Specialist
Physical Attributes:
• May sit for extended periods of time.
• Utilize dexterity abilities to perform typing, operate a computer and other office equipment, to perform filing, and related job responsibilities and attention to detail competence.
• Spend significant time reading both on paper and on a computer.
Work Environment:
• General office environment.
• Noise level in the work environment is usually quiet to moderate.
Minimum Qualifications:
• Bachelor's degree in business, quality control management, industrial engineering or related field
• 6+ years of Quality or related experience
Preferred Qualifications:
• Experience in the medical device industry (FDA and Health Canada Quality System Regulations)
• Experience in a metric-driven culture, emphasizing performance/process improvements
• Experience in quality audits and analysis
• People management experience, including coaching, performance feedback, and day-to-day support for direct reports.
• Strong troubleshooting, critical thinking, organizational, and verbal/written communication skills
• Strong attention to detail
• Experience in SAP and electronic quality management systems
• Basic computer skills (Microsoft Office)
Salary: $128,250 - $156,750/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.
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.
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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 : Andover (MA)
Travel Percentage: 0 - 10%
Requisition ID: 19596
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.
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E-Verify Participation
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Straumann Group EEO-AA Policy
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