Quality Compliance Specialist

The Quality Compliance Specialist is responsible for supporting the Bruker Spatial Biology Quality Management System (QMS) processes. Primarily responsibilities will include leading QMS activities of Internal Audits, Quality Assurance (QA) product release, administration of change management and document control processes of creating and modifying standard operating procedures. Ensure consistent implementation, improvement, and compliance to the Bruker Spatial Biology Quality System and global regulatory requirements, including, but not limited to, the FDA Quality System Regulation (QRS), Canadian Medical Device Regulatory (CMDR), ISO 9001, ISO 13485, and In-Vitro Diagnostic Directives (IVDD).

Responsibilities:

Lead, coordinate, and execute quality audits programs (Internal, Supplier and Regulatory), process/product improvement projects, and disposition activities
• Plan and execute Annual Management Reviews
• Administer the Change Management and Document Control system.
• Responsible for Final QA product release and associated/ supported documentation e.g COAs and/or deviations.
• Lead creation and modification updates for SOPs, work instructions, and other quality documentation.
• Review quality records for completeness and compliance with QSR and ISO requirements.
• Maintain eQMS electronic documentation system and compliance
• Participates in FDA/ISO inspections and customer audits and ongoing audit readiness.
• Perform other relevant duties as may be assigned by management.
• Act as Quality ambassador providing decisive approach for implementation to manage Quality Management System with various projects, as required

Skills and Abilities:

• Analytical decision-making skills to apply logical or Quality and Compliance thinking principles to operations using pragmatic approaches.
• Demonstrates working knowledge of ISO 13485 quality system and/or FDA 21 CFR 820 quality regulations.
• Interpersonal skills to interface with all levels of the organization, management, customers, and suppliers.
• Good written and verbal communication skills.
• Quality Lead Auditor Certification
• Experience in the medical device or diagnostic industry is a plus

Specialized Knowledge:

• Strong understanding of applicable regulations and standards (21 CFR 803, 806, 820, ISO 13485 and ISO 9001).
• Analytical, Problem Solving and training skills.
• Practical experience/training in quality systems management, internal / external audits, change management and document control processes, quality auditing, root cause analysis, and problem-solving are highly desirable.

Minimum Education: Bachelor's degree in a related field strongly preferred.

Minimum Experience : 5-8 years quality-related experience in biotech, the pharmaceutical or consumer regulated device industry.

At Bruker, base salary is part of our total compensation. The estimated base salary range for this full-time position is between $63,000 and $110,000 provides an opportunity to progress as you grow and develop within a role.The base salary for the role will depend on a several job-related factors, including, but not limited to education, training, experience, the geographic location of the successful candidate, skills, competencies, job-related knowledge and travel requirements for this position. Full-time employees may also be eligible for a performance-related incentive in addition to a full range of benefits including 401(k) with company match, an employee stock purchase plan, medical and dental plans, life insurance, short-term and long-term disability insurance, employee assistance program and paid time off including vacation, sick time and holidays, and more.

Bruker is an equal-opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

Certain positions at Bruker require compliance with export control laws and as a result, all interviewed candidates for all positions will be screened pre-interview to determine their eligibility in light of export control restrictions.