Full Time Fda Inspector Jobs (NOW HIRING)

The scope of this position is includes performing all necessary quality control checks, including FAI's and associated reports (First Article Inspection & Reports), using appropriate testing procedures and test instrumentation supported with appropriate documentation for all Bruker Spatial Biology products to manage quality risk and provide oversight over manufacturing processes. This position reports into the Sr. Quality Manager which is part of Quality organization and support associated tasks and activities coordinated and integrated with production and inventory control. The individual ensures consistent implementation, improvement, and compliance to the Bruker Spatial Biology, ISO 13485 and ISO 9001 Quality Management Systems.

Responsibilities:

• Perform timely incoming and final quality control inspections to support Manufacturing and Operations quality for all Bruker Spatial Biology instruments following approved and active Incoming Specifications
• Update incoming inspection specifications and procedures as required, in collaboration with other cross-functional departments.
• Record non conformances and support in conducting root cause investigations.
• Manage nonconforming (or potentially nonconforming) material through disposition.
• Perform lot validation testing while monitoring and adjusting testing frequencies.
• Support review and updating of SOPs relating to Quality Control Procedures.
• Collaborate with Manufacturing, Manufacturing Engineering, New Product Introduction, Procurement, Quality, and Supply Chain partners as well as vendors on the above activities.
• Basic application of statistical tools and methods
• Participates in FDA/ISO inspections and customer audits and maintain 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 tasks, projects, as required

Skills and Abilities:

• Analytical decision-making skills to apply logical or Quality control thinking principles to operations using pragmatic approaches.
• Demonstrates working knowledge of ISO 9001, ISO 13485 quality system and/or FDA 21 CFR 820 quality regulations as applicable to products.
• Analytical and creative problem-solving skills that include experience in leading and or participating on process improvement/lean projects.
• Excellent written and oral communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Ability to multi-task with demonstrated problem solving skills in a fast paced complex environment

Specialized Knowledge:

• GD&T and CMM skills is preferred
• At least 3 years of experience as a QC inspector in a regulated environment i.e. medical device/ biotechnology/ aerospace industry.

Minimum Education: Bachelor’s degree in a related field strongly preferred OR High school STEM or technical diploma or equivalent BS in technical discipline, real world hands-on regulated industry experience may also be considered.

Minimum Experience : 3-5 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 $41,500 and $66,000 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