Sr Manager, Quality (Onsite)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

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.

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

Career Advancement Opportunities

This position leads the Quality function in the Asheville, North Carolina facility and is a member of the Site Leadership Team! The successful candidate for this role will be responsible for working with the site to develop and deploy a world class quality and compliance strategic plan that applies Lean, Continuous Improvement and Statistical Process Control to deliver high quality temperature control products to our customers. The ability to build a rapport with all colleagues at the site is important in order to lead a culture of compliance across the site. The ability and desire to mentor early career colleagues in accurate root cause investigations, process validations and compliance systems is also needed.

What will you do?

• Maintain a Quality Organization by anticipating and identifying customer needs and priorities and integrating them into the Quality System
• Ensure the site maintains continued compliance to ISO 13485, 21CFR820, EU MDR, DEA, Customer Requirements and others.
• Establish goals and objectives that stretch boundaries by detailing specific continuous improvement activities focused on enhancing internal process and test yields
• Interact with Customers and Suppliers, when required, to promote external relationships or resolve opportunities.
• Promote LEAN Enterprise approaches with a quality focus that includes Daily Standard Work and continuous focus on processes.
• Create and maintain both a Quality-centric and Quality-focused culture for all production activities
• Perform all job duties in a safe manner and obey all safety policies and procedures
• Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).

Education:

• Bachelor's degree required, a degree in Engineering, Quality Management, Bio-medical or related field is preferred.
• ASQ Certification (CQE, CQA, CSSGB, CSSGB) Preferred

Experience:

• 8 years of experience in dynamic roles with manufacturing companies producing electro-mechanical products
• 5 years of experience in a leadership role
• Regulatory experience in International Standards ISO-13485:2016, EU MDR and 21 Code of Federal Regulations (CFR) Part 820 Food and Drug Administration (FDA) Quality Systems Regulation (QSR) is preferred
• Excellent planning, organizational and communications skills.
• Experience in leading teams in the implementation of quality improvements systems resulting in reduced cost and cycle times with improved quality of products and services

Knowledge, Skills, Abilities:

• Effective presentation skills to communicate to all levels on issues that include Quality Plans and Quality Management Systems, performance metrics and improvement systems
• Knowledge of Quality Engineering principles.
• Able to travel (domestic and international) up to 10%