Quality Specialist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

EDUCATION

A Bachelor’s Degree is required. A science major preferred.

EXPERIENCE

• Minimum of 2 years’ experience in a Quality Assurance function in an ISO 13485 environment. Familiarity with the life sciences industry is desired.
• Auditing experience; ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred.
• Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages

KNOWLEDGE, SKILLS, ABILITIES

Strong critical thinking skills, with a close attention to detail and history of good judgment
Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and comfortable with learning and using new software programs
Strong technical writing skills
Proven ability to work in a team and matrixed environment
Driven and resourceful, with minimal to moderate direction required
Proven ability to prioritize work according to urgency and impact, with good time management skill

• Lead Quality Compliance activities and QMS improvement initiatives, projects, and gap assessments to establish necessary improvements.
• Maintain Quality Systems’ compliance to ISO 13485:2016 standards and regulatory requirements and policies as applicable.
• Lead and host site’s quality management reviews including issuance and delivery.
• Own the Detroit Site’s internal audit program, responsible for schedule planning and adherence, auditor training, and timely resolution of resulting observations through root cause analysis and the application of effective corrective action
• Support or lead external audits (e.g. customer, corporate, notified body)
• Respond to compliance-related customer inquiries in a timely manner, including but not limited to preparing certificates of origin and other regulatory documents, supplier questionnaires
• Oversee change management program, including customer notification policy
• Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners
• Support the execution of the site’s training program
• Maintain Quality records according to Thermo Fisher Scientific policies and procedures
• Support Quality record reviews including, but not limited to, batch history records, equipment and calibration documentation, QC records, and shipping records.
• Support timely delivery of products to customers with lot release (raw materials and manufactured product) and preparation of certificates of analysis
• Other projects will be assigned as various business needs arise
  How will you get here?