A BRIEF OVERVIEW

The Site Quality Manager assures compliance and progress towards the established goals of the organization as the quality department head by developing and enforcing quality standards and good business practices. They communicate and ensure customer expectations and regulation requirements are met. The Site Quality Manager reports to the business unit Quality Director.

WHAT YOU WILL DO

• Work positively and enthusiastically to promote a quality culture and engage the organization.
• Be a coach to your team, and develop the organization's strength through empowering the team, and driving curiosity and resilience.
• Act as a leader within the business, both in developing and delivering Quality objectives, but also acting as business partner in delivering wider business goals.
• Use your knowledge of regulated industry to drive a mindset of delivering compliance, whilst ensuring that this is achieved through building a depth of understanding throughout the organization, and working cross-functionally to ensure compliance is well understood and responsibilities are clear.
• Engender a quality culture throughout the business, holding regular briefings with employees to champion the quality cause continually.
• Be an advocate of Lean Manufacturing and use this mindset to work alongside leadership to plan and develop the activities and priorities to develop a Quality System which is compliant, yet agile
• Promote and coach, ‘’quality at the source’’ and understand the role of variation reduction and process capability in driving quality performance
• Develop the organizational competence in Problem Solving methodology and be competent in coaching Problem Solving
• Ensure the organization develops a data analysis framework and systems which supports efficient reporting, decision making and supports prioritization.
• Lead Environmental Compliance and Employee Health and Safety at the site, however you will partner with the Plant Manager and HR Manager in delivering excellence in this area, whilst being supported by an EHS Lead. You should expect to engage the full organization in this area of collective responsibility.
• Lead and develop team members following the company’s approach to select, manage, and develop our best team. Ensure the growth of our positive business culture through behaviors that align with our core values and leadership competencies.
• Ensure team members have the required knowledge and skills prior to performing job duties independently, including conducting, documenting, and evaluating training effectiveness.
• Assists in the Non-conformance and Corrective and Preventive Action (CAPA) processes to ensure timely responses to quality issues
• Provides daily quality decisions and direction on product-related issues
• Interface with customers regarding quality concerns topics that include, but are not limited to metrology, inspection techniques, quality paperwork/certifications, and performance scorecards
• Conceive, present, and lead continuous improvement projects related to Quality Control and Document Control
• Track and trend internal and external quality metrics to proactively solve problems
• Participate in internal and/or external audits to ensure compliance to procedures and regulatory requirements
• Utilize company global processes to meet Key Performance Indicators (KPIs) for Quality that support Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and facility financial objectives
• Participate in regular RPN reduction activities linked to the PFMEA process to proactively prevent quality or manufacturing-related problems
• Lead change efforts to improve internal rework and scrap to improve KPI Metrics

EDUCATION QUALIFICATIONS

• Bachelor (Required)
• Master (Preferred)

EXPERIENCE QUALIFICATIONS

• 5+ Years of Experience in Quality (Required)
• 5+ Years of Experience in a Leadership Role (Required)
• 2+ Years of Experience in a Leadership Position in a Manufacturing Environment (Preferred)
• 8+ Years of experience in Quality (Preferred)
• 5+ Years of Experience with Quality Systems in a Highly Regulated Industry (i.e. Medical Devices, Aerospace, Pharmaceutical, Food, or Nuclear) (Preferred)

LICENSES AND CERTIFICATIONS

• Certified Manager of Quality/Organizational Excellence (CMQ/OE) - American Society for Quality (ASQ) (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Accuracy and Attention to Detail - Extensive Experience
• Change Leadership - Extensive Experience
• Communication - Working Experience
• Customer Communication - Working Experience
• Computer Knowledge - Working Experience
• Data Analysis Tools - Extensive Experience
• Decision-Making and Critical Thinking - Working Experience
• Inspection Knowledge - Extensive Experience
• Manufacturing Industry - Working Experience
• Organization - Working Experience
• Power BI - Basic Knowledge
• Standard Operating Procedures - Extensive Experience
• Leadership - Working Experience
• Problem Solving - Working Experience

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

ADDITIONAL REQUIREMENTS

• Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
• Candidates must be able to provide proof of eligibility to work in the United States through eVerify

EOE, including disability/vets

WHAT WE OFFER

• Opportunity to work in a growing company
• Ability to help people live a longer, more active life
• Comprehensive benefit package
• Ability to work in an organization that values integrity, teamwork, and results.

Job Type: Full-time

Schedule:

• 8 hour shift

Application Question(s):

• Why are you interested in this particular position?
• Why are you leaving your current position?
• What are your salary expectations?
• Based on the job description, what skills and experience do you have that directly relate and make you an ideal candidate for the position? What do you see as your biggest challenge coming into the role?
• If we spoke with your current (or most recent supervisor) or colleague, how would they describe you?
• If offered a position, what date would you be available to start?
• Where do you see yourself in 5 years?
• How many years of experience do you have directly managing people?
• How would you describe your leadership style?
• Do you require sponsorship now or in the future?
• Do you have any prior experience in the medical device industry?

Education:

• Bachelor's (Required)

License/Certification:

• ASQC Certification (Required)

Work Location: In person