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Straumann Group · 7 hours ago

Quality Manager

Andover, MA

Full-time

Onsite

Senior Level

$128K/yr - $157K/yr

6+ years exp

Straumann Group develops and supplies dental solutions, and they are seeking a Quality Manager to provide overall quality support to the organization. The role involves managing the Quality Management System to ensure compliance with FDA and Health Canada requirements and leading various quality assurance initiatives.

Medical Device

Responsibilities

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

Qualification

Quality Management SystemFDA RegulationsQuality AuditsSAPPeople ManagementBasic Computer SkillsCritical ThinkingOrganizational SkillsVerbal CommunicationWritten CommunicationAttention to Detail

Required

Bachelor's degree in business, quality control management, industrial engineering or related field

6+ years of Quality or related experience

Preferred

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)

Benefits

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!