Senior Compliance Engineer, Production

Illumina San Diego , CA 92140

Posted 1 week ago

Position Summary:

The Senior Compliance Engineer, Production is chartered with leveling up our quality maturity in the manufacturing organization. This function will be responsible to reduce quality defects in our business and manufacturing processes and provide practical GMP guidance to our manufacturing teams. The team will own and execute root-cause investigations, implement action plans for nonconformances, internal/external audits and other compliance related matters.

Responsibilities:

  • Supervises the mfg. compliance organization. Including execution to Illumina Quality systems: NC, CAPA, Complaint processes; audit support.

  • Grows talent within the organization by leading employee development initiatives.

  • Manages prioritization of team resources and deliverables.

  • Participates in the definition of area goals and drives teams to deliver on goals.

  • Provides day to day management of employees for the team and team members.

Leadership Responsibilities:

  • Supervises the mfg. compliance organization. Including execution to Illumina Quality systems: NC, CAPA, Complaint processes.

  • Grows talent within the organization by leading employee development initiatives.

  • Manages prioritization of team resources and deliverables.

  • Participates in the definition of area goals and drives teams to deliver on goals.

  • Provides day to day management of employees for the team and team members.

  • Works with a cross functional team to ensure that compliance gaps are appropriately addressed.

  • Ensure projects/improvements are implemented within stated goals and timelines.

  • Lead the manufacturing compliance team in defining project strategies, developing goals, assigning project tasks, and ensures the team members meets goals. Gives team members performance evaluations.

Function Responsibilities

  • Owns and drives all manufacturing NCRs, CAPAs, and customer complaints.

  • Supports audit readiness and on-site audits.

  • Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.

  • Establish and support best practices for problem solving, root cause analysis, and solution selection tools.

  • Tracks KPIs related to health of quality systems,

  • Drives continuous improvement initiatives to advance quality processes and capabilities.

  • Advocates strategic and operationally effective solutions to complex problems.

  • All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities

  • Using investigation/lean tools develops robust root cause analysis and drives robust actions to ensure elimination of root cause.

  • Interacts through program updates and reviews with all levels of management.

  • Participates with other managers in setting the project strategy, schedules, resource alignment, and financial analysis.

  • Approves team deliverables for project completion

  • Provides technical support in all phases of investigation. Teaches others to use investigation/lean tools to resolve nonconforming situations.

  • Anticipates and resolves conflict situations in a win- win outcome.

  • Utilize engineering tools to solve straightforward problems (e.g., FMEA, Finite Element Analysis, Process Modeling, Design of Experiments, Mold Flow, SPC, software development).

  • Study and recommend techniques to improve existing products/processes.

  • Select sound techniques to solve problems and make design recommendations under direction of supervisor. Assess results for application, validity and conformance to specifications.

  • Assists in the training of more junior team members.

Leadership Requirements:

  • 1-2 years of experience in managing people/resources effectively to accomplish established goals;

  • Ability to negotiate and influence cross-functionally.

  • High emotional intelligence with demonstrated ability to set a course and bring his/her peers forward with them.

  • Experienced in leading culture change initiatives.

  • Experience in implementing and leveraging metrics.

  • Adaptable to fast-paced, dynamic work environment and shifting demands.

  • Extremely strong communication, interpersonal skills and customer focus.

  • Strong leadership skills with demonstrated ability to effectively work across teams and functions.

  • Must be able to look at processes high level as well as zoom in on a detailed level.

  • Proven capacity to effectively manage and escalate risk.

Function Requirements:

  • 3-5 years of experience in quality assurance in a regulated environment (FDA, EMA, ISO13485); direct experience working in in-vitro diagnostic manufacturing preferred.

  • Strong background in GMP manufacturing.

  • Knowledge of lean tools and root cause analysis methodologies.

  • Ability to work in a matrix organization.

  • Project management skills preferred.

Education:

  • Bachelor's degree in an engineering or scientific discipline.

  • Graduate degree in an engineering or scientific discipline and/or business strongly preferred.

Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you have a disability or special need that requires accommodation, please contact us at applications@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf


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Senior Compliance Engineer, Production

Illumina