Associate Manager, Advanced Quality Engineering in Portage, MI at Stryker Corporation

Date Posted: 7/2/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Portage, MI
  • Job Type:
    RAQA
  • Experience:
    Not Specified
  • Date Posted:
    7/2/2018
  • Job ID:
    30491BR

Job Description

Provides leadership and direction to the new product development quality function, ensure compliance to global medical device regulations, and drive improvements in internal systems and processes.  Responsible for building, developing, and managing the performance of engineers and technicians.  
Essential Functions:
 

  • Provide leadership for a new product development projects, managing pre-market quality activities in accordance with regulations and business and customer needs.
  • Influences the establishment of the Quality department strategy with a strong understand of business, corporate, and regulatory needs. Supports the implementation of a team strategy in alignment with the department strategy. 
  • Assure the requirements of 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable government regulations or international standards are implemented and maintained (including those of all MDSAP countries).
  • Responsible for supervision of engineers and technical employees.
  • Operate within an established annual budget and quarterly forecasts. Make necessary changes with appropriate management involvement.
  • Communicate and collaborate with Quality, Regulatory, R&D, Operations and Marketing departments to ensure divisional and corporate goals and strategies are met.
  • Navigates challenging situations by partnering with cross-functional teams to deliver customer satisfaction while ensuring compliance to legal and regulatory requirements
  • Serve as a subject matter expert for one or more new product quality processes.
  • Establish standard processes for consistent quality deliverables and provide management oversight of responsible task owners.
  • Represent quality processes during internal and external audits.
  • Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.
  • Recruit, select, and on-board top talent.
  • Develop talent within the team to increase performance. Actively address performance issues on team.
  • Responsible for acting as a customer advocate in regard to product quality, including safety, reliability, durability, craftsmanship, and performance.
  • Influences Corporate Quality System process within areas of direct responsibility

QUALIFICATIONS:
 

  • BS in science or engineering
  • Master’s degree preferred
  • 5 years of professional experience required
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
  • Demonstrated 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 prioritize and manage multiple project workloads
  • Demonstrated experience with trending and analysis reporting
  • Demonstrated leadership skills
  • Demonstrated process improvement and management skills
  • Experience with recruiting and people development
  • Influence across the organization
  • Maintain a high level of team engagement


Work From Home: No

Travel Percentage: Up to 25%

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.

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