Job Description
About the Company
Our client forms lasting partnerships with customers to design, develop, manufacture and bring to market innovative engineered solutions for demanding medical device, biotech and pharmaceutical applications. They act as an extension of customer project teams to help them realize their goals, whether an accelerated time to market, efficient scale-up, a consistent, quality supply, or any combination thereof. Their experienced teams are focused specifically on serving the medical markets and delivering value to customers globally through a strong set of core capabilities.
About the Role
The quality manager develops and achieves quality initiatives to support company goals and objectives. You’ll oversees the validation and verification requirements of new products/programs as well as ensuring that all related quality activities are carried out in accordance with industry standards and regulations. This role manages overall quality resources and ensures that capacity and capability meet the customer demand. You’ll also optimize human and capital resources through continuous improvement activities.
Responsibilities
- Provides leadership, guidance, and technical expertise to the quality team and site
- Manages and oversees all aspects of the quality team involved in quality related product/program development projects from conceptualization and validation phase through release to manufacturing
- Must be knowledgeable and adhere to the quality management system and its requirements
- Drives and supports QMS initiatives and continuous improvement activities
- Ensures direct reports are successfully performing their duties as assigned; provides coaching on an ongoing basis
- Assigns projects and responsibilities to the direct reports; ensures skill-sets of staff are in alignment with expected duties
- Consults customers on quality-related topics
- Establishes and develops site-specific processes as required/requested
- Reviews and approves processes, quality plans, protocols/reports, as necessary
- Ensures proper resource allocation to support needs to ensure delivery expectations of customers
- Provides recommendations for goals and objectives for the quality department
- Works closely with internal resources to establish processes and resolve issues
- Drives best practices through the application of effective quality engineering principals and procedures across functions
- Ensures proper controls are being systematically applied to both new and legacy products
- Supports internal and external audits
- Provides recommendations based on data for improvements that are measurable
Education + Experience
REQUIRED
- 4-year degree in engineering or science-related field
- 8+ years of increasing experience providing technical support and leadership in medical device manufacturing environment, including CMO, or a similar highly regulated environment
- 4+ years of leadership/supervisory-level experience with decision-making authority/responsibility
- Quality certifications (ASQ CQE, CQA, CQM, etc.) preferred
- Class I, II, III medical device manufacturing experience preferred
- Knowledge and experience with ISO/FDA: ISO 13485, EU/MDR, GHTF validation guidance, and 21CFR Part 11/820 (and 4/210/211 as applicable)
DESIRED
- Experience in coaching and utilizing performance management tools and disciplines
- Extensive experience with statistical analysis, Minitab software (or equivalent), GD&T and CAPA investigation and resolution
Competencies
- Ability to read, write, speak and understand the English language
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Ability to demonstrate adequate job knowledge to deliver a world class performance
- Ability to challenge oneself to consistently meet all goals and deadlines
- Willingness to strive for excellence by producing work that is free of errors and mistakes
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
- Commitment to making improvements company wide
- Demonstrated competence using Microsoft Office
- Demonstrated active leadership skills
- Demonstrated ability to lead projects and get results through others
- High level of professionalism and collaboration in team settings
- Ability to manage tasks with competing priorities and deadlines
- Proven team building skills
- Strong Statistical background and understanding
- Ability to lead cross functional groups for continuous improvement projects
- Ability to apply Six Sigma methodologies to manufacturing processes and experience teaching others these techniques
- Strong verbal, written, organizational and interpersonal skills; ability to communicate clearly and effectively to customers either in person or via video or telephone conference
- Professional and proactive; able to work well independently or as part of a team
- Ability to work flexible schedule as required by workload/project