Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance. We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.
As the Quality Engineer we are looking for the right candidate to utilize design, engineering and quality principles and practices to support the design and manufacture of products and implement and improve key business and quality processes.
1. Works with internal and external stakeholders and managers to define issues, select projects and prioritize work. Assure projects align with business and quality system objectives. Create project charters, work plans, schedules, issues logs, and risk management plans as necessary.
2. Develops project, process, instrument and product plans addressing key requirements, deliverables, timing, and assignments needed for successful completion. Write or establish methods or procedures to ensure continued and improved process and system performance.
3. Implements project, process, instrument or product work in collaboration with other partners, departments or teams. Create assignments and tasks and track completion against stated requirements. Address delays and other barriers in completion of tasks.
4. Reports and/or presents project, instrument or product progress/metrics to stakeholders during course of work. Identify issues detrimental to the timeline, budget or quality of the work, and recommend solutions to overcome identified issues.
5. Uses quality, engineering and human factors concepts, design and implement product and process improvements to improve quality and lower costs. Ensure products and processes meet customer, business and regulatory requirements.
6. Actively manages partners, suppliers, contractors and consultants in delivering solutions during project work.
7. Designs, develops, redesigns and manages products and processes which are compliant with customer requirements, the Quality System Regulation (QSR) and ISO13485. Key systems include Design Control, Process Controls, Supplier Controls and other related QS sub-systems.
8. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
1. Represents Promega in discussions/interactions with partners, suppliers or customers as requested.
2. Assists with or lead cross-departmental or corporate projects or initiatives as assigned.
3. Works with management with executive responsibility on urgent/critical activities or projects needed for the business.
4. Acts as internal resource in process evaluations and human factors design.
1. Minimum BS degree or equivalent in engineering, technical and/or scientific discipline with minimum 4 years of engineering or design experience.
2. Minimum of 2 years’ experience in project management or supervision, especially in the biotechnology or medical device areas.
3. Demonstrated knowledge and experience in various computer skills, including Windows, Word for Windows, Excel, Outlook, Visio, Microsoft Project, CAD as well as familiarity working in a windows-based environment.
4. Demonstrated experience in achieving results in a rapidly changing cross-functional environment.
5. Strong analytic and presentation skills for problem determination, decision-making and resolution.
6. Over 2 years’ experience in designing, developing and supporting biotechnology or medical device product lines.
1. Independent, self-starter with proven results in problem identification, planning, communication and project management.
2. Able to work and communicate well with a diverse scientific, business, and organizational groups to achieve improvement and operational results.
3. Experience in medical device and cGMP systems, especially in understanding requirements, identifying improvement targets, tracking results, and developing products.
4. Excellent oral and written communication skills, including formal presentations, coaching, and problem resolution.
5. Ability to articulate technical and interpersonal issues, and resolve conflict in a constructive manner to ensure project success.
6. MS or greater in engineering or technical discipline.
1. Ability to work with computers.