Engineer/Scientist II, QC

Position Objective

The Quality Engineer II will lead develop investigation plans, lead investigation execution, and assist in development of corrective action plans of quality issues related to customer complaints, corrective action requests and quality improvement requests. Interfaces with customers regularly to ensure products meet expectations.

Key Objectives of the role:

• Lead cross-functional team members supporting the Customer Feedback/Complaint Handling Process & CAPA process.
• Monitor product quality improvement to ensure execution of actions including any resulting customer communications/interactions.
• Execute Risk and Impact Assessments
• Interface directly with customers and internal groups.
• Develop realistic solutions to meet customer needs and solve problems
• Drive product and process changes to improve product quality.
• Communicate recommendations and decisions across the organization.
• Use problem solving tools (8D, 5-whys, cause and effect, etc) to drive resolutions.
• Lead in a fast-paced technical environment, absorb technical information, review technical information and make technical decisions.

Knowledge

Expert knowledge of:

• Strong analytical, problem solving, and teamwork skills are required.
• Experience at effectively communicating complaints, risks, production, process controls, Corrective and Preventive Action (CAPA) and improvements.
• Strong Root Cause / Corrective Action skills.
• Ability to analyze and process data and draw the appropriate conclusions.
• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies, in-depth understanding of products and processes
• Experience prioritizing conflicting demands
• Excellent interpersonal, organizational, and influencing skill.
• The ability to perform independently and as part of a team.
• Ability to analyze and process data, and draw the appropriate conclusions
• Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
• Excellent communication, written and presentation skills.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. As we continue to grow, you’ll have career advancement opportunities and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Now is an exciting time to join manufacturing team! We are dedicated to ensuring our customers receive the products they need to achieve their scientific goals quickly and safely.

Proficiency in:

• Site specific software programs (change control notification program, CAPA, etc.).
• Global Systems e.g. Trackwise, AGILE, E1/SAP
• Microsoft tools Word, Excel, Power Point, Teams.

Minimum Qualifications (must have):

• Bachelor’s degree in related Science/Engineering field or 5 years direct Quality Engineering experience.
• 3 years’ experience in medical device, biotech or pharmaceutical industry in an Engineering, Quality or Regulatory related role.
• Direct experience of working with ISO 13485 and 21CFR820

Competitive wages & Excellent benefits package:

• Review our company’s Total Rewards
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Holidays
• 401K Company Match up to 6%
• Tuition Reimbursement – eligible after 90 days
• Employee Referral Bonus
• Employee Discount Program
• Recognition Program
• Charitable Gift Matching
• Company Paid Parental Leave

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary : $40 - $0