Senior Quality Engineer jobs in Germany

In this role, you will monitor and control the daily activities of quality inspections of incoming, in-process, final, and batch record review and release. In his position, you will manage the Quality Control team to ensure inspection process is executed in a proper and timely manner by ensuring procedures are followed and improved as part of a continuous improvement mindset.

• Provides direct supervision, resolves personnel issues, conducts performance evaluations, and performs managerial discipline, as necessary.

• Direct reports include quality control supervisors

• Leads and directs the Incoming Inspection, In-Process Inspection, and Batch Release teams with a positive and patient attitude.

• Maintains and instills in others a “quality at the source” mentality as it pertains to all aspects of manufacturing, including documentation, training, and other functions related to production.

• Maintains and instills in others an “immediate audit readiness” mentality so that records and actions are executed in a way that ensures their accuracy, legibility, and immediate retrievability.

• Ensures compliance with quality system documents, cGMPs, ISO standards and FDA regulations.

• Schedule and prioritize quality inspection, testing, and batch record review and release to support Operations and release of product.

• Identifies and develops opportunities to improve existing processes and procedures

• Support quality assurance improvement activities by evaluating products, processes or materials in order to develop control or improvement strategies intended to improve the customer’s experience.

• Work with technical staff in performing root cause failure analysis and implementing corrective and preventive actions to eliminate recurrence.

• Manage the verbal communications and visual checks of work activity to ensure quality requirements are met. Ensure proper corrective actions, discrepancy reports and follow up activities are accomplished.

• Reviews documentation and records for accuracy. Determines if product is impacted, can be released, or if Non-Conformance Report is required.

• Manages the development of documentation and procedures during the qualification of new equipment/inspection methods.

• Exhibits regular, reliable, punctual and predictable attendance.

• Creates, prepares, implements and improves Quality Control KPIs metrics.

• Determines/sets Goals and Objectives for the Quality control organization and training programs for team's development purposes.

• Supports investigations related to Non conformances, Audit observations, CAPAs, or Issue Reviews as needed.

• Ensures equipment is up to date on Preventive maintenance and calibration activities.

• Maintains the QC area well organized with a 5S mindset.

• Other duties as assigned

• Participate in special project teams as assigned.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all laws, regulations, safety rules, policies, and work procedures, and all instructions.
• Exhibits regular, reliable, punctual and predictable attendance.

• Associate's Degree Associate's Degree in Technical or Engineering required or
• Bachelor's Degree Degree in Technical or Engineering preferred

• Minimum 8 years previous experience in Quality Control required and
• Experience in FDA regulated environment, pertinent to ISO 15378 preferred

• Must be familiar and proficient with computers and various software programs such as Microsoft Word, Microsoft Excel, Master-control, SAP
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Metrology Equipment experience
• Leadership experience in leading teams preferred

• This job requires decision making based on data analysis
• Must be able to generate, express, and exchange new ideas
• Must be able to understand direction and adhere to established procedures
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problemsAdaptable to changes in the work environment, manage competing demands and deal with frequent change, delays, or unexpected events.

In this role Senior Specialist, Fill Finish Process, you will join our growing team, and support customers with technical questions related to our Integrated Systems portfolio, mainly focusing on fill/finish topics, such as glass handling, rubber component transportation, plunger setting, outer packaging. You’ll bring hands-on experience and deep fill/finish process knowledge, you will be an integral part of this team and support our customers in all their process-related questions.

In this role, you will act as a trusted technical consultant, visiting production sites and directly advise them on optimizing their processes based on your fill/finish expertise. Internally, you will serve as a Subject Matter Expert, collaborating with peers to align on best practices and holistically shape how we communicate with customers. You will lead studies with fill/finish equipment vendors globally and publish the results as internal and external communication material.

• Provide hands-on support to customer, including on-site visits to troubleshoot their processing and optimize the fill/finish operations
• Plan and coordinate technical studies with fill/finish equipment vendors or C(D)MOs,
• Develop holistic approaches to customer-facing content related to fill/finish topics; this includes technical reports, bullet-ins, and other scientific communications
• Establish and maintain customer communication related to fill/finish topics,
• Coordinate internal exchanges on fill/finish topics
• Develop internal & external trainings by supporting the creation and editing of training material (presentations, publications, blogs, success stories, and other communication materials)
• Analyze customer’s requirements by evaluation and thorough assessment of the technical aspects of the manufacturing process
• Participate in technical discussions with customers with a high level of technical proficiency
• Support the implementation of new technologies, component systems, change parts, and other process related activities to support ongoing and new projects. This work may include process improvement activities and product transfers
• Lead resolution of process challenges related to our components
• Prepare and manage process documentation (protocols, change controls)
• Other duties as assigned

• Bachelor’s degree in Engineering or equivalent experience

• Minimum 5 years of hands-on experience in pharmaceutical processing and packaging technology, working with multiple different fill/finish lines, aseptic filling, and isolator technology

• Profound knowledge in filling line technology
• Ability to handle scientific & technical content with legal and regulatory understanding,
• Ability to make sound and independent judgments,
• Ability to clearly and concisely communicate and comprehend complex ideas and concepts
• Sound knowledge of scientific terminology, medical, pharmaceutical, and research concepts
• Sound skills in scientific writing, grammar, and spelling in English
• Must be able to multi-task, work under time constraints, problem-solve, and prioritize
• Adaptable to changes in the work environment, manage competing demands, and deal with frequent change, delays, or unexpected events
• Maintain high attention to detail, accuracy, and overall quality of work
• Adept in word processing, spreadsheets, tables, presentations, and graph generation
• Capability to work well in a matrix environment with R&D, QA, Legal, Regulatory Affairs, Product Management, Technical Customer Support, Sales, Marketing, Product Technology Service, and Global Communications
• Ability to analyze research data and review experimental protocols
• Entrepreneurial problem solver with strong troubleshooting skills

• Must be able to travel up to 40% of the time, both domestically and internationally, and sometimes on short notice
• Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction
• Maintain the ability to work well with others in a variety of situations
• Able to learn and apply new information or new skills

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully execute supplier management plans which will align to overall business objectives
• Maintain a strong collaborative partnership with external suppliers and cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs

• Monitor supplier performance including incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)
• Execute Supplier Corrective Action Requests (SCAR) with suppliers, ensuring effective and timely closure
• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance including supplier change request.
• Evaluate potential new or future suppliers and support supplier selection process with the cross-functional team
• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers during product development and ensures agreement for manufacturable, cost-effective designs
• Approves components for use in products by driving Product Approval activities with the suppliers
• Supports Supplier evaluation, audit management and related records
• Supports the evaluation and development of Quality Agreements and purchasing specifications with suppliers
• Support the development of an Incoming Inspection strategy on purchased products

• Bachelor's Degree in Science or equivalent experience required
• Master's Degree in Science or equivalent experience preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

In this role, you will be responsible for planning, organizing, and leading projects to support the development of new packaging systems and or components. Drive technical projects, work with cross-functional development teams, and work with strategic suppliers to develop new packaging systems. Subject matter expert for component packaging and drive technical decisions which support West's business objectives.

• Technical packaging lead for Research and Development efforts related to product design and development processes from conceptualization to commercialization
• Engage with cross-functional teams to develop new packaging solutions
• Develop innovative packaging solutions to support business growth and to enhance West’s position as an industry leader in containment and delivery
• Responsible for creation and maintenance of packaging elements for Design History File (DHF) for all assigned projects including Design Inputs, Risk Analysis (FMEAs), test protocols, and Design Verification
• Support customers and suppliers as required for development of new packaging solutions
• Coordinate packaging testing activities for engineering studies and protocols through internal and contract packaging laboratories
• Deliver technical reports, executive summaries, and presentations to communicate activities and timelines to management and core team members
• Identify and drive continuous improvement efforts within the packaging group

• Maintain effective communications and working relations with all external parties

• Bachelor's Degree Packaging, Materials, Chemical Engineering or related engineering or scientific discipline or equivelant experience required
• Master's Degree Packaging, Materials, Chemical Engineering or related engineering or scientific discipline preferred

• Minimum 5 years in package engineering or related role required
• Technical project leadership experience from concept through commercialization preferred
• Previous knowledge or experience with aseptic pharmaceutical processing preferred
• Experience in communicating complex technical concepts to customers and internal stakeholders preferred
• Experience in working under requirements of Quality Management System in a regulated environment preferred

• Working understanding and application of fundamental engineering principals
• Strong technical writing abilities
• Thorough understanding or global testing standards and regulatory requirements related to sterile barrier packaging
• Excellent interpersonal and written/verbal English communication skills