Site Investigation Lead, Quality Assurance

Reliability Lab Test Engineer

Manufacturing Engineer

Facilities Engineer

SR R&D - Product DVL Engineer

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Responsibilities: <ul><li>Lead reliability planning and testing activities for new and existing products.</li><li>Define and implement reliability test plans based on product specifications, usage environments,&nbsp;and customer expectations.</li><li>Conduct Failure Mode and Effects Analysis (FMEA), Root Cause Analysis (RCA), and statistical&nbsp;analysis to identify and mitigate risks.</li><li>Collaborate closely with Design, Quality, Manufacturing, and Product Development teams to&nbsp;ensure reliability is embedded in the product life cycle.</li><li>Develop and maintain reliability models, such as Weibull analysis, and interpret results to guide&nbsp;engineering decisions.</li><li>Support qualification testing, including environmental, mechanical, and electrical stress tests.</li><li>Interface with customers to provide technical support and reliability data when needed.</li><li>Document and present reliability reports, metrics, and improvement actions to stakeholders.</li><li>Mentor and guide junior engineers within the reliability or cross-functional teams.</li></ul> Requirements: <ul><li>Bachelors or Master’s Degree in Mechanical, Electrical, Electronics Engineering or related field.</li><li>Minimum 5-7 years of relevant experience in reliability engineering, preferably in electronic&nbsp;components or a manufacturing environment.</li><li>Strong knowledge of reliability testing standards (e.g., IEC, MIL-STD, JEDEC).</li><li>Experience with statistical tools and software (e.g., Minitab, JMP).</li><li>Hands-on experience in conducting HALT/HASS, thermal cycling, vibration, and environmental&nbsp;testing.</li><li>Excellent problem-solving skills and experience with tools like 8D, Ishikawa, and FMEA.</li><li>Effective communication skills, both written and verbal.</li><li>Ability to work independently and in a team-oriented, cross-functional environment.</li></ul>

Responsibilities: New Project: In order to ensure that the mass production project can meet the production requirements and achieve the purpose of on-time delivery: <ul><li>Design and improve the mass production expansion PN assembly equipment, FSR sample production and inspection</li><li>Follow up the mass production project to expand P/N samples and expand business, and make external sample requirements</li><li>Guide technicians to debug assembly equipment and make samples</li><li>Take safety protection measures and implement the companys EHS standards and requirements</li></ul> Production Problem Handling: In order to ensure the normal operation of daily production, reduce scrap and downtime: <ul><li>Track and analyze production engineering problems and provide solutions</li><li>Guide technicians to solve production engineering problems</li><li>Cooperate with QE to jointly handle customer quality complaints</li></ul> Production process improvement: In order to improve production efficiency and reduce costs: <ul><li>Find improvement points, formulate improvement plans and implement improvement actions with other relevant departments</li><li>Communicate with ECO in a timely manner about improvements in product design</li></ul> Production equipment repair and maintenance: In order to ensure the good operation and safety of production equipment and molds: <ul><li>Formulate equipment and mold repair, maintenance and overhaul plans and supervise technicians to implement</li><li>Check the safety protection devices of the equipment and implement the companys EHS standards and requirements</li></ul> Production Document Preparation and Management: To ensure the completeness and timeliness of production documents: <ul><li>Prepare and update engineering documents (such as work instructions, production flow charts, FMEA, etc.)</li><li>Follow up and implement engineering changes</li></ul> Requirements: Education, Technical Qualification &amp; Experience: <ul><li>Bachelor degree or above Mechanical/engineering related major</li><li>5 years of relevant work experience CET-4</li></ul>

Responsibilities: <ul><li>Responsible for system operation including cleanroom, MAU, Dry Coil, FFU, AHU, CDA, Process Vacuum, PCW, Chiller, Cooling tower, Pumps System, Acid Scrubbers &amp; Exhaust system, Solvent Exhaust, General Exhaust system, Calamity Exhaust system, Fire protection and fire alarm system, air conditioning, etc.</li><li>Develop, maintain and review operational &amp; maintenance procedure and ensure facilities equipment operate in optimum level (efficiency, healthy, safe, etc.) together with Plant Facilities.</li><li>Review predictive and preventive maintenance of the system for continuous improvement together with Operation &amp; Maintenance.</li><li>Evaluate and review system operation/design to reduce cost and improve system reliability.</li><li>Support, coach and guide technicians in operation &amp; maintenance, troubleshooting, etc.</li><li>Interface with Engineering, Operation, EHS for equipment, preventative/correction maintenance program and projects and compliance with various regulatory procedures.</li><li>Ensure good documentation (hardcopy and softcopy) of facilities system</li><li>Aspect impact, FMEA, SDS, risk assessment, control plan&nbsp;</li></ul> Mechanical Facilities System Capacity Management: <ul><li>Capacity Review</li><li>Drawing Management</li></ul> Responsible for Mechanical Facilities System Training: <ul><li>Develop and maintain training material:</li></ul> Conduct training: <ul><li>Responsible for Mechanical System Maintenance. Review maintenance contract to ensure adequate maintenance suit to facilities system.</li><li>Work Order Support to close all defects and issues on time.</li><li>Facilities Projects Support – Infrastructure/Clean room/Facilities System (Upgrade, Expansion, Modification, Retrofit, Improvement, Robustness, Energy Saving, etc.)</li><li>Feasibilities Studies and Technical Review for Projects</li><li>Project Specification Preparation</li><li>Project Execution</li><li>Project Buy-Off</li><li>Facilities Expansion Plan</li></ul> Manufacturing Support: <ul><li>Plan and execute Facilities POU Readiness for Equipment hookup</li><li>Support in Equipment hookup&nbsp;</li><li>Work with Equipment, Process Engineering, Production, Industrial Engineering, EHS, etc. on operation issue/expansion projects/improvement projects/etc.</li></ul> Requirements: <ul><li>Degree holder preferable in Engineering or equivalent.</li><li>Min. 3 years in similar capacity and working experience in related field</li><li>Ability to work on multiple tasks and projects concurrently</li><li>Self-motivated and able to work independently</li></ul>

Role Description: <ul><li>For our product development team for electro-mechanical relays in the Centre of Competence in Waidhofen/Thaya in Austria, we are looking for a Senior Product Developer (m/f/d) to strengthen the team. </li><li>As a product developer, you will be responsible for supporting product management and sales with innovative product solutions. Our products are developed for the global market and have been on the market for many years (&gt;15 years). </li><li>As a Product Development Engineer, you will develop these products from the initial idea through to series production. The position reports directly to the Head of Product Development.</li></ul> Responsibilities: <ul><li>Main development engineer responsible for electro-mechanical relay platforms and platform extensions.</li><li>Independent development of innovative product solutions in compliance with the relevant standards.</li><li>Coordination of product requirements with field application engineers, product management and customers.</li><li>3D design and creation of 2D product drawings •	Carrying out feasibility studies and tests.</li><li>Management of Design for Manufacturing (DFM) and Design Failure Mode and Effects Analyses (DFMEA)</li><li>Collaboration with Ansys simulation experts and our in-house laboratory as well as prototyping.</li><li>Working in an international working environment.</li></ul> Requirements: <ul><li>Bachelors degree in mechatronics (an advantage), mechanical engineering, electrical engineering with professional experience.</li><li>Experience with the realisation of development projects.</li><li>Experience with project management is an advantage.</li><li>3D CAD design experience (preferably PTC Creo or similar parametric CAD programmes).</li><li>Creative and analytical mindset and problem-solving skills.</li><li>High level of innovation and ability to work in a team.</li><li>Good English Knowledge, German an advantage.</li><li>Main development engineer responsible for electromechanical relay platforms and platform extensions.</li><li>Independent development of innovative product solutions in compliance with the relevant standards.</li><li>Coordination of product requirements with field application engineers, product management and customers.</li><li>3D design and creation of 2D product drawings.</li><li>Carrying out feasibility studies and tests.</li><li>Management of Design for Manufacturing (DFM) and Design Failure Mode and Effects Analyses (DFMEA).</li><li>Collaboration with Ansys simulation experts and our in-house laboratory as well as prototyping.</li><li>Working in an international working environment.</li></ul> Location: <ul><li>Waidhofen/Thaya, Austria (remote location near the Czech Republic border).</li></ul>

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5 fmea Jobs found

Site Investigation Lead, Quality Assurance

Reliability Lab Test Engineer

Manufacturing Engineer

Facilities Engineer

SR R&D - Product DVL Engineer

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5 fmea Jobs found

Site Investigation Lead, Quality Assurance

Reliability Lab Test Engineer

Manufacturing Engineer

Facilities Engineer

SR R&D - Product DVL Engineer

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