Sr. Quality Engineer

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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• Evaluate all relevant operational data, reports, statistics and documentation related to manufacturing process and product performance in the field, in order to generate proactive and timely actions when needed to reduce CIPM.
• Assure product compliance to specifications through implementation of inspection criteria and procedures in operation’s processes. Drives quality and manufacturing improvements to ensure our processes are in state of control.
• Develop and analyze statistical data and product specifications to ensure product quality.
• Apply standard operating practices and problem-solving methodology.
• Perform root cause investigation analysis and prepare reports, for negative trends of process or product failures or critical characteristics not being met.  Document such actions within the quality system as appropriate (NCR/CAPA).
• Organize, review and perform computer system validation or other software validation related evaluations to support the Master Validation Plan. Support the data integrity initiatives to relevant systems, processes and equipment.
• Develop and maintain Risk Management Documentation including software risk for all product families or software defects.
• Perform validation activities as assigned (DQ, IQ, OQ, PQ, TMV, etc.).
• Partner with Project and Manufacturing Engineering to ensure the smooth transition of projects into day-to-day operations and software changes.
• Evaluate and/or perform computer system validation for applicable software or GxP computerized systems per Client.
• Analyze and perform assessments for software change controls for computer system validation, data integrity, hardware interactions and cyber security impact.
• Provides coaching and mentoring to the organization regarding CSV, SDLC, data integrity and cyber security standards, regulations, guidance, and best practices.
• Other duties as assigned.

• Demonstrated experienced on process validation and risk management for medical device.
• Engineering depth and ability to understand product and process operating principles, control points and methods, design and process interactions and end user impact.
• Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.
• Must be able to update procedures and modify processes to simplify complexity and improve efficiencies.

• Minimum of a BA or BS in Engineering having a minimum of 3 to 5 years related experience or demonstrated performance within Quality Engineering.
• A Master’s degree can be used in lieu of 2 years of related experience.  Engineering or Business Administration major is preferred.
• Lean or Six Sigma Green Belt or higher is preferred.

• Climbing. Ascending or descending ladders, stairs, scaffolding, ramps, poles and the like, using feet and legs and/or hands and arms. Body agility is emphasized. This factor is important if the amount and kind of climbing required exceeds that required for ordinary locomotion.
• Standing. Particularly for sustained periods of time.
• Walking. Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another.
• Talking. Expressing or exchanging ideas by means of the spoken word. Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
• Hearing. Perceiving the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound.

• Light work. Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the worker sits most of the time, the job is rated for light work.

• The worker is required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned (i.e., custodial, food services, general laborer, etc.) or to make general observations of facilities or structures (i.e., security guard, inspection, etc.)

• The worker is subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.