Qa Manager Jobs in Rochester, MN (NOW HIRING)

Work Schedule

Environmental Conditions

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.

This QC Technician II position is based at our Rochester, NY site and supports our Quality Control operations on 3rd shift. The role works closely with Manufacturing, Quality, and Engineering to help ensure components and finished assemblies meet established quality requirements in an ISO/GMP manufacturing environment.

As a QC Technician II, you will help ensure that products manufactured at our Rochester facility meet established quality standards before they are accepted and released. You will perform inspections and testing, review quality documentation, support nonconformance activities, and partner cross-functionally to maintain product quality and compliance.

• Follow established quality procedures, work instructions, Quality Work Instructions (QWIs), Quality Control Inspection Plans (QCIPs), specifications, and applicable quality requirements.

• Perform inspections and testing of components and assemblies using QC measuring and testing equipment.

• Set up and properly operate QC inspection and testing equipment and identify equipment that is not functioning properly or is unsuitable for use.

• Accurately and completely document inspection and testing activities in required quality records.

• Interpret and apply QA specifications, Standard Test Procedures (STPs), engineering drawings, and other applicable technical specifications.

• Perform specialized QC testing that requires additional training and is not routinely performed by Manufacturing inspection personnel.

• Complete SAP Quality Management (QM) notification activities associated with the nonconformance/NCR process.

• Maintain quality records in accordance with applicable device history and batch record requirements.

• Review completed lot files and electronic records for accuracy, completeness, and documentation errors prior to product disposition.

• Perform usage decisions for standard product files and support the maintenance and storage of batch records.

• Support product release activities involving variances, reworks, requests, and other assignments as directed by the QC Supervisor.

• Communicate inspection results and quality concerns effectively with Quality, Manufacturing, and Engineering personnel.

• Participate in corrective action activities and support investigation and resolution of quality issues.

• Support Engineering work orders requiring a higher level of complexity than routine Manufacturing inspection activities.

• Support QC auditing activities to help ensure quality requirements and expectations are consistently met.

• Maintain clear and effective communication throughout the workday and during shift handoffs to ensure continuity of Quality operations.

Required:

• Minimum of a high school diploma or GED

• Experience using SAP Quality Management System.

• Minimum of 1 year of experience in Quality Assurance, Quality Control, manufacturing inspection, or a related field.

Preferred:

• Experience working in a cGMP, GMP, ISO-regulated, or similarly controlled manufacturing environment.

• ASQ certification or other relevant quality certification.

• Ability to read, understand, and follow quality procedures, work instructions, inspection plans, test procedures, and technical specifications.

• Ability to read and interpret engineering drawings and apply applicable specifications during inspection activities.

• Working knowledge of inspection and measurement techniques and the ability to properly use QC measuring and testing equipment.

• Ability to recognize equipment or measurement conditions that may affect the validity of inspection results.

• Strong attention to detail with the ability to accurately complete and review quality documentation.

• Understanding of nonconformance processes and the ability to accurately document quality issues.

• Ability to use SAP QM or similar electronic quality/manufacturing systems.

• Ability to maintain accurate records in accordance with applicable quality system and documentation requirements.

• Effective verbal and written communication skills, including the ability to clearly communicate inspection findings and quality concerns.

• Ability to collaborate effectively with Quality, Manufacturing, and Engineering teams.

• Ability to prioritize assigned work and perform responsibilities independently while following established procedures.

• Demonstrated commitment to quality, compliance, safety, and continuous improvement.

• Ability to work 3rd shift in a manufacturing and Quality Control environment.

• Ability to perform detailed visual inspections and use inspection, measurement, and testing equipment for extended periods.

• Ability to remain seated or standing for periods of time while performing inspection and documentation activities.

• Ability to move between Quality Control and manufacturing work areas as required to support production activities.

• Must be able to follow applicable site safety procedures and wear required personal protective equipment (PPE).

• Competitive pay

• Performance-related bonus where eligible

• Annual merit performance-based increases

• Medical benefits

• Paid Time Off/Annual Leave

• Employee Referral Bonus

• Career Advancement Opportunities

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards