Senior CQV Engineer

Senior CQV Engineer

This is an onsite daily opportunity

What You ll Do

You will be responsible for performing quality oversight & approval of validations change controls records & projects to ensure consistent deliver of high quality documents processes products and processes.

MAIN PURPOSE OF ROLE

This position is responsible for providing quality support and oversight on product process and equipment related changes and implementations (validation & change control). Specifically

Provide quality support and oversight (approval) of process and equipment validation and change control records and activities

Ensure that facilities utilities and equipment (FUE) used in the support of the Quality System are validated and maintained in compliance with regulatory and Abbott requirements

Review documentation (e.g. validation records/reports change control records periodic reviews etc.) for accuracy clarity consistency completeness and compliance

Plan and complete assignments with a wide degree of difficulty while maintaining milestones established in the project schedule

Analyze data procedures and requirements to ensure quality and compliance

Collaborate with alternate functional teams (including but not limited to engineering operations regulatory program management and other quality teams) to ensure consideration is given to financial and business outcomes when making quality decisions

Coordinate activities across multiple project groups

Accept ownership and responsibility for decisions

Effectively engage with team members within Abbott and third party manufacturer (TPM) teams and

Provide leadership guidance coaching and training to various functions and colleagues.

Report unexpected events or issues which occur during validation to project team and management.

Apply sound systematic problemsolving methodologies in identifying investigating assessing impact and resolving unexpected events or issues which occur during validation.

Perform quality oversight & approval of equipment process and validation documentation and change control records (e.g. pFMEAs URSes protocols reports SOPs work instructions process flow diagrams ECs etc.)

Review documentation for accuracy clarity consistency completeness and compliance to internal and external requirements for multiple projects

Drive strategy of FUE & process validation for new or changing products processes facilities equipment etc.

Ensure that appropriate procedures controls and recovery plans are incorporated into equipment system process and/or product implementations/changes.

Work with cross functional teams to ensure quality and compliance requirements are considered during activities (e.g. work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities)

Drive to meet validation schedule as aligned with project(s) goals.

Works independently with objectives given by the Quality Manager.

Plan and coordinate own work according to higher level project schedules.

Support (as needed) the investigation resolution and prevention of product and process nonconformances CAPA investigations or other quality system records.

Identify areas for process improvement and provides supporting information for change including reasons and justifications.

Assist team members and cross functional colleagues in meeting their goals by providing coaching and mentoring as needed.

Participate in or lead teams in supporting quality disciplines decisions and practices (e.g. represent the Quality function as a Core Team Member).

Support projects and Divisional initiatives as identified by management.

Performs other related duties and responsibilities on occasion as assigned.

Requirements

Bachelors Degree Engineering or Technical Field or an equivalent combination of education and work experience

EXPERIENCE

Minimum 5 years experience in medical device/pharmaceutical manufacturing

Process Validation experience and demonstrated use of Quality tools/methodologies.

Detailed knowledge of FDA GMP ISO 13485 and ISO 14971.

Strong project management and leadership skills including the demonstrated ability to lead multidepartmental project teams and resolve qualityrelated issues in a timely and effective manner

Prior medical device validation experience preferred.

Experience implementing various product and process improvement methodologies (e.g. Six Sigma and Lean Manufacturing).

Ability to work within a team and as an individual contributor in a fastpaced changing environment.

Ability to leverage and/or engage others to accomplish projects.

Ability to maintain regular and predictable attendance