Aktiv Pharma Group

Aktiv Pharma Group is hiring for a Quality Engineer (QE) position. We are a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system. This position offers an exceptional opportunity to work alongside the founder and CEO, and thus be integral to executive team meetings, prioritization and decision making. This position is ideal for a confident, driven, critical thinker who both follows instructions and works well independently, and can work well with a wide variety of people. The ideal candidate is someone who can understand the big picture to support the CEO's vision, goals, agenda and priorities, while also being organized and detail-oriented in their task execution. This position requires accomplished verbal and written communication skills, as well as the ability to gather and interpret information with quick turnaround.

At Aktiv Pharma Group, we value the diversity of perspectives and backgrounds our employees bring. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We work according to our values of truth, caring, goodness and perseverance, and encourage individuals with the required skillsets and these values to apply.

General Purpose

The Quality Engineer (QE) leads the development, implementation, and maintenance of the quality engineering methodologies, systems, and practices which meet Medical Device/Combination Product regulatory standards concentrating on the application of Design Control, Risk Management and incoming component quality management.

Essential Duties/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• Builds and supports the Quality Engineering function by providing intelligence, discipline, problem solving and collaborative skills that can improve designs and processes.
• Investigates non-conforming events and product failures as they relate to Design Controls to drive product and process improvements with the objective of compliance safety and

high customer satisfaction.

• Authors and/or maintains the Design Control portion of the Quality Management System (QMS) that encompasses all the Standard Operating Procedures (SOPs) that are required by the Federal Drug Administration (FDA) for medical device/combination products.
• Ensures designs, tests, risk analysis, and human factors activities for Aktiv Pharma Group's (Aktiv's) products are safe and effective for use.
• Ensures risk management is effective by using feedback from validation, field service, post market surveillance, manufacturing indicators, corrective and preventative actions (CAPAs), etc., including maintaining the risk management SOP.
• Provides input and guidance on the use of various statistical techniques and quality tools.

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

• Ability to consistently promote, support, work, and act in a manner in support of Aktiv's mission, vision and values.
• Must have solid experience in Risk Management for medical devices ISO 14971
• Strong ability for application and leading problem-solving, root cause analysis and related CAPA.
• Must be able to interface well with others, especially Manufacturing Engineering, Research and Development (R&D) Engineering, and Regulatory.
• Experienced with statistical techniques, including design of experiments (DOE); able to analyze results.
• Ability to work independently, with excellent organizational, communication, leadership and problem-solving abilities.

Education or Formal Training:

• A Bachelor's degree with CQE experience or BS in Mechanical Engineering, Biomedical

Engineering, Process Engineering, Analytical Chemistry, or related technical discipline is required.

Experience:

• Minimum of five (5) years of experience in a medical device environment is required with a portion of that directly involved in Design Control from concept to sunsetting is preferred.
• An equivalent combination of education and experience may be substituted on a year to year basis.

Additional Requirements/Licenses/Certifications:

• ASQ (American Society for Quality) certified or Certified Quality Engineer or equivalent is preferred.
• Must have reliable transportation.
• Valid driver's license
• Infrequent Domestic travel may be required

Aktiv meets or exceeds all local, state and federal requirements as they pertain to COVID-19.