Quality Specialist II (Supplier Quality Acceptance)

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Loud Noises (Equipment/Machinery) Office Standing for full shift Working at heights

Job Description

How You Will Make an Impact:

The Quality Specialist II Supplier Quality Acceptance supports product quality and supplier performance by independently performing supplier quality acceptance activities for materials components fabricated assemblies and equipment used in single-use bioprocessing and automation systems. This role evaluates product and documentation conformance against approved drawings specifications purchase requirements inspection plans and quality standards; identifies and documents nonconforming conditions; and supports timely resolution of supplier quality issues. The position applies sound quality judgment objective evidence and risk-based decision making while collaborating with Supplier Quality Engineering Operations Procurement Project Management and suppliers to .ensure compliant and timely product acceptance protect manufacturing and customer commitments and drive continuous improvement in supplier quality performance. This role requires up to 50% travel to supplier and other business locations throughout North America to perform supplier quality acceptance source inspection FAT/HAT and related quality activities.

Day In The Life:

• Independently perform supplier quality acceptance activities at supplier sites receiving locations and other designated locations using approved engineering drawings specifications purchase requirements inspection plans quality requirements and defined acceptance criteria.
• Inspect mechanical and electrical components fabricated assemblies and equipment including stainless-steel vessels fabricated hardware electrical enclosures controllers wiring welds surface finishes dimensions workmanship and other defined product characteristics.
• Select and use appropriate inspection and measurement equipment and methods to verify dimensions mechanical and electrical characteristics surface finish weld quality electrical connections workmanship and other defined product characteristics and acceptance requirements.
• Review and interpret engineering drawings specifications Bills of Materials (BOMs) tolerances/GD&T quality requirements and acceptance criteria to determine applicable inspection and acceptance requirements and identify gaps or ambiguities requiring clarification.
• Review supplier work and manufacturing progress against approved drawings specifications quality requirements and acceptance criteria and identify conditions that may affect product quality acceptance readiness project schedules or delivery.
• Perform or support source inspection receiving acceptance in-process verification Factory Acceptance Testing (FAT) Hardware Acceptance Testing (HAT) validation and related quality acceptance activities to verify conformance and acceptance readiness prior to shipment receipt handover or release.
• Review supplier quality documentation and objective evidence required for acceptance including certificates inspection records material documentation calibration records test reports and other applicable quality records for completeness accuracy traceability and conformance to defined requirements.
• Document inspection results acceptance status discrepancies and supporting objective evidence in inspection reports logs ERP/eQMS records and other required systems ensuring records are accurate complete timely and traceable.
• Make objective acceptance rejection or escalation decisions within established procedures and delegated authority based on documented requirements inspection results objective evidence and product or quality risk.
• Identify and document nonconforming conditions when supplier products processes documentation or records do not meet defined requirements.
• Escalate significant recurring high-risk or potentially systemic supplier quality issues to Supplier Quality and Quality leadership as appropriate.
• Collaborate with Supplier Quality Engineering Operations Procurement Project Management Quality and suppliers to clarify technical and quality requirements resolve acceptance issues and support timely product disposition and acceptance.
• Clearly communicate acceptance status discrepancies nonconformances deviations required follow-up and unresolved quality concerns to suppliers and appropriate internal stakeholders.
• Provide inspection findings objective evidence and technical quality input to support supplier quality reviews issue resolution risk assessment and quality-related project decisions.
• Maintain professional and effective supplier communication while supporting practical compliant and timely resolution of quality issues.
• Support disposition activities by providing objective inspection evidence and clearly identifying the applicable requirement that was not met.
• Initiate or support nonconformance supplier corrective action and Corrective and Preventive Action (CAPA) activities as applicable including containment objective-evidence collection investigation and root-cause analysis support follow-up and verification of completed corrective and preventive actions.
• Support supplier/fabricator readiness by communicating inspection expectations acceptance requirements documentation needs and identified quality concerns prior to or during acceptance activities.
• Track recurring inspection findings nonconformance trends and supplier defects and provide quality data and observations to support supplier performance monitoring and improvement activities.
• Identify and recommend improvements to inspection methods acceptance criteria checklists work instructions documentation practices and quality records based on lessons learned and recurring issues.
• Support implementation and consistent application of standardized inspection methods acceptance criteria and documentation practices across supplier quality acceptance activities.
• Participate in Practical Process Improvement (PPI) and continuous improvement initiatives focused on supplier quality inspection effectiveness defect reduction process consistency and acceptance cycle time.
• Perform supplier quality acceptance activities in accordance with applicable quality-system GMP data-integrity documentation environmental health safety and regulatory requirements.
• Follow applicable Thermo Fisher Scientific and supplier-site safety requirements and use required PPE and safe work practices while working in manufacturing fabrication receiving testing and supplier environments.
• Maintain complete accurate attributable and traceable quality records in accordance with applicable documentation and data-integrity requirements.
• Perform other duties as assigned to support evolving BEA Santa Clara business needs.

The responsibilities described above are representative of the nature and level of work performed and are not intended to be an exhaustive list of all duties and responsibilities.

Education & Experience:

Required:

• Advanced Degree in Engineering Quality Life Sciences Manufacturing or a related technical field; OR

Bachelors Degree in Engineering Quality Life Sciences Manufacturing or a related technical field with 2 years of relevant experience in regulated manufacturing bioprocessing equipment capital equipment or a comparable engineered product environment; OR

Associate Degree in an engineering or related technical discipline with 4 years of relevant experience in regulated manufacturing bioprocessing equipment capital equipment or a comparable engineered product environment; OR

High School Diploma or equivalent with 6 years of experience in regulated manufacturing bioprocessing equipment capital equipment or a comparable engineered product environment.

• Relevant experience includes supplier quality source inspection incoming inspection manufacturing quality quality acceptance validation or comparable quality activities supporting mechanical and/or electrical components fabricated assemblies capital equipment or other engineered products.
• Experience performing quality inspection or acceptance activities against engineering drawings specifications inspection plans or defined acceptance criteria.
• Experience documenting inspection and quality results within controlled quality ERP eQMS or electronic record systems.
• Experience identifying and documenting nonconforming conditions and supporting nonconformance supplier corrective action CAPA or related quality investigation processes.
• Experience reviewing supplier/manufacturing quality documentation and objective evidence.
• Experience using inspection and measurement equipment appropriate to mechanical and/or electrical components and assemblies.
• Experience interpreting engineering drawings specifications tolerances Bills of Materials and quality requirements.

Preferred:

• Experience working directly with suppliers or fabricators.
• Experience with stainless-steel fabrication weld inspection surface finishes and fabricated equipment.
• Experience with fabricated equipment used in pharmaceutical biotechnology bioprocessing food cosmetic medical-device or other regulated manufacturing environments.
• Experience with FAT HAT source inspection supplier acceptance or customer-facing project execution.
• Experience with ERP eQMS and document-control systems.
• Experience with single-use bioprocessing equipment vessel hardware automation systems or capital equipment.
• Familiarity with sampling plans and acceptance criteria.
• Experience with supplier corrective-action processes.

Knowledge Skills Abilities:

• Strong working knowledge of quality inspection product acceptance nonconformance and supplier quality practices.
• Ability to independently evaluate product and documentation conformance against approved drawings specifications purchase requirements inspection plans and acceptance criteria.
• Ability to make objective risk-based quality acceptance rejection or escalation decisions within established procedures and delegated authority.
• Strong ability to read and interpret mechanical and electrical drawings specifications Bills of Materials inspection plans dimensional tolerances GD&T and quality requirements applicable to supplier acceptance activities.
• Working knowledge of mechanical and electrical inspection techniques applicable to fabricated components assemblies equipment wiring welds dimensions surface finishes and workmanship.
• Working knowledge of inspection procedures sampling methods inspection plans and acceptance criteria applicable to supplier quality acceptance activities.
• Proficiency using applicable inspection and measurement tools including tape measures calipers micrometers profilometers optical tachometers and other hand or measurement tools required for assigned inspection activities.
• Ability to identify nonconforming conditions document clear objective evidence and support containment disposition and corrective-action processes.
• Knowledge of quality documentation traceability document control and data-integrity requirements.
• Ability to review supplier certificates inspection records material documentation calibration records test reports and other objective evidence for completeness and conformance.
• Ability to support defined quality and acceptance processes during equipment qualification hardware acceptance and related supplier activities while maintaining process consistency and quality expectations.
• Strong analytical and problem-solving skills with the ability to identify recurring quality issues recognize trends and escalate potential systemic concerns.
• Strong attention to detail and commitment to inspection accuracy documentation quality traceability and consistent application of acceptance requirements.
• Strong written and verbal communication skills with the ability to communicate acceptance status nonconformances technical findings and required actions clearly to suppliers and internal stakeholders.
• Strong cross-functional collaboration skills with the ability to work effectively with Supplier Quality Engineering Operations Procurement Project Management and suppliers.
• Ability to manage multiple supplier acceptance activities and priorities independently while meeting project and delivery requirements.
• Ability to work effectively in supplier manufacturing fabrication receiving and testing environments with minimal supervision.
• Ability to identify nonconforming conditions document clear objective evidence and support containment investigation root-cause analysis disposition supplier corrective action and CAPA processes as applicable.
• Working knowledge of GMP quality systems nonconformance management supplier corrective action CAPA and applicable regulated-manufacturing requirements.
• Proficiency with Microsoft Office and applicable ERP eQMS document-control and quality-record systems.

Physical Requirements and Work Environment:

• Combination of office-based quality work and regular activity within manufacturing fabrication receiving testing and supplier environments.
• Regular use of computers laptops tablets ERP/eQMS document-control and quality systems for extended periods.
• Frequent standing and walking while performing inspection acceptance and supplier-quality activities.
• May require bending kneeling reaching crouching climbing ladders or accessing equipment at floor level to inspect components assemblies vessels electrical equipment or other products.
• Manual dexterity required to safely handle and operate inspection and measurement tools and equipment.
• Required use of appropriate PPE when entering designated manufacturing fabrication testing receiving or supplier work areas.
• Exposure to manufacturing/fabrication equipment metalworking environments electrical equipment and moderate noise levels as applicable to the work environment.
• Ability to lift and carry inspection equipment tools materials or components up to 35 lbs.
• Requires up to 50% travel by air and ground transportation to supplier and other business locations throughout North America.
• May require schedule flexibility to support supplier acceptance activities FAT/HAT schedules project requirements travel or other business-critical quality activities.

Compensation and Benefits

The salary range estimated for this position based in Minnesota is $60000.00$80000.00.

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: Experience:

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