Quality Assurance 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 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.

• Program Activities:
• • Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
  • Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
  • Report on the progress of projects; identify successes; and drive compliance.
  • Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
  • Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.
  • Support design transfer activities for commercial and launch readiness and sustainment.
• Verification and Validation Activities:
  • Review and approve test method validations (protocols and reports).
  • Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
  • Facilitate and support the completion of projects up to and including PQ.
• Risk Management Activities:
  • Responsible for authoring and/or reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
  • Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.
• QMS Activities:
  • Support enterprise procedures updates that impact design and development activities.
  • Drive the closure of change controls and protocol non-conformance reports (PNRs).
  • Review and draft relevant procedures and forms for the management of activities connected with product design & development.
  • Act as the interface between development teams and operational quality:
  • Perform first article component and product inspections
  • Draft defect libraries and quality inspection documents during OQ; and manage formal hand over of same to Operational Quality prior to PQ.
  • Support the supplier selection process in accordance with West supplier management procedures.
  • Conduct and support internal and supplier audits, as required.
  • Lead internal audits of R&D and support site QA in the preparation and hosting of third party and customer audits.
  • Lead and manage QMS activities including CAPAs, Failure Investigations, Non-Conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management. Provide direction on non-conformances, deviations, or excursions and drive to closure.
  • Actively engage in robust problem-solving to address quality issues.
• Metrology Activities:
  • Review and approve metrology data during OQ & PQ.
  • Support Quality Function Deployment activities (QFD).
• Compliance to all enterprise and local company policies and procedures.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Perform additional duties at the request of the direct supervisor.

• Bachelor's Degree in Chemistry, Engineering or Quality discipline required

• 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.

• Desirable: Regulatory Affairs experience

• Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
• Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
• Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
• Experience in Project Management
• Experience in process technology, by preference with elastomers.
• Risk Management experience within design and development with good working knowledge of ISO 14971.
• An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing.
• Knowledge of analytical tools and methods, including statistics (Minitab preferred).
• Must be able to organise and prioritise tasks.
• Must have critical reading skills, maintain a high attention to detail and overall quality of work.
• Must be self-motivated, able to prioritize and multi-task, work independently and make sound judgements, work under time constraints, thrive in face-paced environments.
• Strong problem-solving skills, including root cause failure analysis methods.
• Must have excellent written and verbal communication skills.

• ISO 13485/9001/15378 Auditor or Lead Auditor Training / Certification upon hire is preferred.

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• 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 problems.