Manager, Quality Assurance

Stryker - Leesburg, VA

Full-time
Job Description

Who we want

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.

Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

What you will do

As a Manager, Quality Assurance, you will lead key quality functions in support of new product development and post market sustaining activities. Establish a quality center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvements in quality processes. Oversee the consistency of quality processes. Manage and address potential product and safety investigations through investigation and corrective action.

Responsibilities:
Establish strong collaboration between Quality team members at NJ and VA locations and with other functions including manufacturing, R&D and other business functions.
Manage day-to-day quality processes to ensure issues are appropriately evaluated and resolved.
Determine resource needs and perform recruiting and on-boarding as needed to maintain a competent, efficient and highly engaged team.
Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement.
Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
Serve as Subject Matter Expert for quality processes.
Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
Establish standard process to ensure appropriate resolution and management of the responsible task owner.
Chair meetings required to drive closure of quality issues.
Manage and provide updates for quality metrics. Implement appropriate enhancements.
Represent quality processes during internal and external audits.
Provide guidance and direction for team in support of new product development activities including Risk Management and Design Quality Activities.
Provide guidance and direction for team in support of Post Market sustain activities including Change Control, NC/CAPA and Complaints Handling activities.
Ensure that training curricula and development activities are established to ensure team competency.
Lead quality actions for business development including, due diligence and integration activities.

What you need

Basic Qualifications:
Bachelors Degree in Science, Engineering or related field.
Minimum 7 years’ experience in working in a highly regulated environment, quality, manufacturing or engineering OR minimum 4 years of experience in medical device with at least 1 year of Associate Manager level experience.

Preferred Qualifications:
9 years’ experience in working in a highly regulated environment, quality, manufacturing or engineering preferred.
2+ years management/supervisory experience preferred.
Master's Degree or equivalent preferred.
Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
Demonstrate technical knowledge of medical device product lines.
Demonstrated written, verbal, listening, communication, and team-building skills.
Demonstrated ability to collaborate effectively with and lead cross-functional teams.
Demonstrated ability to effectively prioritize and manage multiple project workloads.
Demonstrated experience with trending and analysis reporting.
Demonstrated knowledge of adverse event reporting, complaint investigation, CAPA, and corrective action processes.
Demonstrated leadership skills.
Demonstrated process improvement and project and/or people management skills.

Work From Home: Occasional

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.