Senior Quality Assurance Engineer - Florida, Weston 3365 Enterprise Avenue

Work Flexibility: Onsite

Stryker is hiring a Senior Quality Assurance Engineer in Weston, Florida to support Joint Replacement! In this role, you will perform internal and external investigations of nonconformances and corrective actions investigations and develop/execute on strategies to reduce occurrence of quality issues (examples: non-conformances, reworks, corrective actions).

In addition, you will work closely with Operations, Global Sourcing and Planning, Advanced Operations, and other manufacturing locations to standardize quality improvements.

Who we want

• Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

• Issue, track, and resolve internal and external (supplier) non-conformances and corrective actions.

• Liaise with internal customers to ensure effective problem resolution.

• Evaluate and determine the internal requirements for approval of all site specific supplier change requests (SCRs).

• Work with internal customers in support of supplier certification activities, including skip-lot, product source and reduced inspection requirements.

• Mentor junior quality engineers on quality assurance.

What you need

Required:

• Bachelor’s degree in engineering or related discipline.

• 2+ years of related experience in a regulated industry.

Preferred:

• Experience in the Medical Device industry preferred.

• Ability to manage project timeline and documentation of completed work.

• MS, CQE, or CRE preferred.

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.

• Familiarity with ISO 13485, GDP, GMP desired.

• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

• Experience in working in a compliance risk situation.

• Highly developed problem-solving skills.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.