Software Quality Engineer

Director, Engineering Services

Quality Control Supervisor

Responsibilities: <ul><li>We develop products in the fields of speech recognition, ambient scribe, and digital dictation. Our products are mainly used in hospitals and medical practices.</li><li>You ensure the quality of our software through automated and manual testing.</li><li>You identify, analyze, and solve simple errors in web applications, iOS, and Android apps.</li><li>You work with E2E testing tools such as Cypress and Detox.</li><li>You collaborate closely with the development team and the Product Owner.</li><li>You support the team with additional testing-related tasks.</li></ul> Requirements: <ul><li>Education in application development or degree in computer science, or several years of experience in test automation (E2E testing) with a focus on web applications or mobile apps.</li><li>Proficiency in TypeScript or another scripting language.</li><li>Strong communication skills with an appreciative style.</li><li>Quick comprehension and independent way of working.</li><li>Strong quality awareness and a passion for testing.</li><li>Very good German skills and good English skills.</li></ul> Other Information: Our Technological Environment: <ul><li>.NET, C#, Web API, Entity Framework, SignalR, WPF, xUnit</li><li>Angular, TypeScript, Electron, Cypress</li><li>React Native, Detox</li><li>Azure DevOps Services with Git</li><li>Microsoft SQL Server</li><li>JetBrains products (Rider)</li><li>Microsoft Windows and Apple macOS as target systems for desktop applications</li><li>iOS and Android as target systems for mobile applications</li><li>Our applications are hosted both in the cloud (Microsoft Azure VMs) and on-premises at our clients’ sites.</li></ul> An Advantage Would Be: <ul><li>Certificate as “Test Automation Engineer” (e.g., ISTQB) or willingness to further your education.</li><li>Experience with CI/CD tools such as Azure DevOps.</li><li>Knowledge of agile methods (especially Scrum).</li><li>Knowledge of database technologies (Microsoft SQL).</li><li>Knowledge of C# and PowerShell.</li></ul> What we offer you (and much more): <ul><li>Alongside a young and modern company culture, you can expect an agile and communicative working environment, great team events, motivating team spirit, and many other benefits:</li><li>A personalized onboarding program so you can fully focus on your new tasks and get to know your new team.</li><li>5 weeks of vacation, increasing to 6 weeks after 3 years, and 7 weeks after 10 years.</li><li>Your birthday off.</li><li>Option to work from home.</li><li>Support and funding for training and further education.</li><li>Free parking, reimbursement of public transport pass, or contribution to your commuting costs, plus a free half-fare travelcard.</li><li>Free coffee, soft drinks, and snacks at the workplace.</li><li>Modern hardware and software, plus a comfortable ergonomic workstation.</li><li>State-of-the-art offices with an in-house game lounge, fitness room, rooftop terrace, and a kitchen with catering options.</li></ul>

Role Description: <ul><li>The Director, Engineering Services leads engineers and maintenance staff to maintain the existing facilities and equipment while developing engineering solutions to operational issues or new processes.</li><li>This position implements capital projects, establishes engineering project objectives and technical criteria for evaluating project results and activities of project team while supporting the policies, goals and objectives of the Company.</li></ul> Responsibilities: Engineering Project Management and Qualification <ul><li>Member of Site Leadership Team</li><li>Develops, plans, coordinates and directs engineering aspects of projects of major scope and importance</li><li>Manages IQ, OQ, PQ program. ?	Manages external engineering services and recommends resources required to carry out projects or improvements</li><li>Routinely has direct contact with outside consultants, technical counterparts from key vendors</li></ul> Facilities and Equipment Maintenance&nbsp; <ul><li>Directs the maintenance staff for routine PM and unplanned repairs of facilities and production equipment.</li><li>Manages calibrations within the plant through in-house or contract services.</li><li>Supports Serialization within the plant.</li></ul> Cross Functional Coordination&nbsp; <ul><li>Supports safety, health, and environmental policies and procedures</li><li>Works with Environmental Health and Safety to ensure city, county, state, and federal regulations relating to the projects and process improvements are met at all times</li><li>Directs, and enforces the safety program for the engineering group and reviews safety records to uphold standards of maximum safety for all maintenance and calibration staff</li><li>Coordinates activities with manufacturing, packaging, logistics, research and development, technical services and IT Departments</li><li>Communicates directly with the operations departments to coordinate engineering activities</li><li>Communicates directly with QA and QC laboratory to ensure effective participation by engineering staff in the implementation of QA policies and procedures</li></ul> Plant/Process Improvement&nbsp; <ul><li>Communicates regularly with all engineers, both individually and as a group, to ensure good two-way communication concerning operational improvements and projects</li><li>Assists with planning and implementing plant improvements and expansions</li><li>Prepares reports, analyzes data, and makes recommendations for improving plant operations and solving manufacturing/packaging-related problems</li><li>Initiates and carries out projects that improve efficiency and/or reduce operating costs</li><li>Coordinates with maintenance and operations staff in reviewing the operation of plant equipment and systems to minimize unplanned downtime, anticipate solve problems in a timely manner, and to identify opportunities for improvement</li></ul> Supervisory Responsibilities&nbsp; <ul><li>Conducts employee performance reviews based on job descriptions to determine competency, knowledge, and contribution of the engineering staff</li><li>Ensures that all engineering staff are trained on the most updated version of the operating procedures</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor of Science in a related technical field plus progressive technical experience and demonstrated competence</li><li>10 years progressive management experience in pharmaceutical engineering, pharmaceutical operations, and operations management</li></ul> Knowledge In-depth knowledge of the pharmaceutical plant operations is an asset Skills &amp; Abilities <ul><li>Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates activities; Makes oneself 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>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>Analytical -Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others ideas and tries new things.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 50 pounds</li><li>Climb ladders and work in high, precarious places up to elevations of 75 feet</li><li>Regularly exposed to work near moving mechanical parts</li><li>Exposed to wet or humid conditions</li><li>Exposed to outdoor weather conditions</li><li>Regularly exposed to high noise environments</li><li>Exposed to extremely dusty environments</li><li>Exposed to chemicals used in the manufacturing process Engineering</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</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><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <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>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>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></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>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

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Software Quality Engineer

Director, Engineering Services

Quality Control Supervisor

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Software Quality Engineer

Director, Engineering Services

Quality Control Supervisor

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