Quality Assurance & Compliance Manager

Who we are:

Accord is a trusted producer of high-value, quality critical products across a variety of industries including the medical, marine, and engineering sectors. Our outstanding reputation has been hard earned and is the culmination of decades of work to refine our craft. Underpinning this is our relentless focus on quality which sits at the heart of our reputation.

We are a customer focused, high paced manufacturing business and pride ourselves in driving our tightknit team to collaborate and deliver on their strengths to ensure we meet and exceed our customers’ expectations. In many instances, our finished products are critical to our customers’ operations, and can be lifesaving. Literally. This includes sophisticated medical respirators, deep sea diving helmets and breathing apparatuses. 

We are now looking for a superstar Quality Assurance & Compliance Manager to join and lead our quality team. Importantly, this role requires both hands-on, shop-floor quality experience, and critical compliance and technical know-how extending across key ISO and regulatory standards. 

About the role:

In this role your key responsibilities will include:

• Leading and managing a team of 2 quality technicians and Accord’s in-house quality management system (QMS). This includes direct management of the internal metrology lab and CMM programming function. 
• Indirect oversight across shop-floor production (40+ FTE) from a quality perspective. Importantly this requires working with key production managers and ensuring BAU quality needs are met. 
• Management of the company’s ISO accreditation, annual auditing requirements, preparation, and conformity. This includes but is not limited to ISO:13485 (medical devices). 
• Producing QC processes and documents and supporting production and assembly personnel to meet ‘First Off’ and validation inspection requirements in a timely and efficient manner.
• Management of new product validations (e.g., pre-production processes such as PPAP). This is particularly important for new medical products.
• Implementation of continuous improvement activities across the quality function, and wider business (e.g., CAPAs).
• Management of key customer audits, notably in the healthcare space. 
• Supporting the team to produce and maintain CMM programs, files, operations, and reports. This is required for many complex, high-quality parts. 
• Providing technical leadership and training for the quality team. 
• Recording and reporting to senior management on the quality performance of the business (e.g., rejects, corrective actions, credit reporting).
• Undertaking process quality control checks and audits across all operations at regular intervals – including internal audits. 
• Operating as the external customer liaison across all key quality matters. This includes reviewing potential part defects, reviewing credit notes, identifying improvement activities etc. 
• Being a genuine team player and working with other functions in the business, when required, to produce excellent business outcomes. Importantly, you will work closely with production and first and foremost, support them.   

To succeed in this role, you will need:

• At least 5-10 years’ experience in a technical quality role and / or as a qualified auditor. This would be extremely well received coming from a medical background, or related industry. 
• Good commercial awareness and social EQ – with the ability to interact with shop floor engineers and clearly understand production needs.
• To be a motivated self-starter, and work in goosestep with production. 
• To be precise and detailed focused, motivated to ensure the production of high-quality components to set standards, tolerances, and timeframes, yet able to maintain a flexible, balanced approach and attitude due to the variety of work and changes in priorities to meet customer requirements. 
• To apply your initiative, eye for detail and passion for quality to support production and assembly operations to get the job done, and work in an open and collaborative way with all stakeholders. 

Key Technical Skills required for the role:

• Good engineering knowledge and understanding of the CNC manufacturing space (e.g., product drawings, manufacturing equipment and software). Additional medical manufacturing knowledge is seen as hugely beneficial.
• Extensive knowledge of key ISO standards, including ISO:13485 (medical). Importantly you have experience leading and managing audits – ideally in the healthcare space, or a related industry. 
• Working knowledge of key compliance requirements in relevant end-user markets. This includes REACH & RoHS compliance measures. 
• Experience with New Product Introduction (NPI) and validations from a quality assurance, control and reporting perspective, ideally in relation to medical products.
• Working understanding of CMM programming.
• Skilled in MS Office and able to create key reporting deliverables for internal / external purposes. 
• Proficiency in measurement and metrology in support of setting, achieving first-off articles within tolerance and maintaining production tolerances.
• Able to interpret technical drawings and models, including GD&T (geometric dimensioning and tolerancing).
• Proven experience in developing quality control documentation for use by production and / or assembly teams.
• Good understanding of SPC (Statistical Process Control).

Desirable, but not essential skills required for the role:

• CNC machining capabilities and experience (potentially working as a shop-floor engineer previously, before moving into a quality role). 
• Industry knowledge extending beyond the medical manufacturing space, including other precision industries (e.g., aerospace, marine, defense). 
• Comprehensive understanding of PCDMIS CMM software and programming, including Aberlink 3D. 
• Good understanding of Haas CNC machinery and capabilities (4, 5-axis).
• Experience with modern production planning and management software systems (ERP).

As a valued member of our team, we can offer you:

• A competitive remuneration package commensurate with skill and experience.
• Attractive progression opportunities including additional management and leadership responsibilities.
• Shortened Fridays – Accord operates a 10-hour shift 4-days a week for shop-floor production staff. Team leaders, while not production, can generally leave earlier on Fridays, workload permitting. 
• Free onsite parking at our factory in Pakuranga. 
• A supportive, fun workplace culture with no hierarchy. Accord is a family environment and not a large corporate.